[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Continent Pharmaceutical Co, Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":241},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,76,103,128,153,174,195,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100613111","phase-1-a-trial-of-hydroxynidone-capsules-in-single-dose-administration-for-patients-with-renal-insufficiency-100613111",false,"NCT07262333","A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency","Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency","Inclusion Criteria:\n\n* The subjects must meet all of the following criteria to be eligible for inclusion:\n* (1) Healthy Chinese subjects, with an estimated glomerular filtration rate (absolute eGFR) meeting the following conditions: ≥ 90 mL\u002Fmin and \\\u003C 130 mL\u002Fmin; (limited to healthy subjects)\n* (2) Patients diagnosed with renal dysfunction, with the estimated glomerular filtration rate (absolute eGFR) for mild, moderate, and severe renal dysfunction meeting the following standards respectively: 1. Mild renal dysfunction 60-89 mL\u002Fmin; 2. Moderate renal dysfunction 30-59 mL\u002Fmin; 3. Severe renal dysfunction 15-29 mL\u002Fmin; (limited to patients with renal dysfunction)\n* (3) Age 18-70 years old, inclusive of 18 years and 70 years old;\n* (4) Weight: Male ≥ 50 kg, female ≥ 45 kg, 18 ≤ BMI ≤ 28 (BMI = weight (kg) \u002F height2 (m2));\n* (5) During the 24 hours before the start of the trial to the end of the trial, the subjects agree to quit smoking, alcohol, fruit juices, caffeine, and tea;\n* (6) Before the trial, they have fully understood the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, and voluntarily participated in this clinical trial, can communicate well with the researchers, comply with all the requirements of the entire study, and have the ability to understand and sign the written informed consent form.\n\nExclusion Criteria:\n\n* The following conditions must be met for a subject to be eligible for this trial:\n* (1) If the subject has participated in any other clinical trial within the three months prior to the trial;\n* (2) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, excluding renal insufficiency, including but not limited to: previous or existing diseases of the heart, liver, digestive tract, immune system and respiratory system (especially any gastrointestinal diseases that affect drug absorption, such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history, active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to patients with renal insufficiency);\n* (3) If the subject has any disease that may affect the safety of the trial or the body's process of the drug, including but not limited to: previous or existing diseases of the heart, liver, kidney, endocrine, digestive tract, immune system and respiratory system (especially cardiovascular diseases including those with cardiovascular disease risk, any gastrointestinal diseases that affect drug absorption (such as irritable bowel syndrome symptoms, intestinal diseases or inflammatory bowel disease history), active pathological bleeding (such as peptic ulcers), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, etc.); (limited to healthy subjects);\n* (4) If the subject has an allergic constitution: if there is a history of allergy to two or more drugs (including the trial drug), food, or lactose intolerance;\n* (5) If the subject has used any drugs that inhibit or induce the liver's metabolism of the drug within 28 days before taking the study drug (common liver enzyme inducers: barbiturates, carbamazepine, amiloride, griseofulvin, amitriptyline, phenytoin, grumet, rifampicin, dexamethasone; common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide drugs);\n* (6) If the subject has used drugs that inhibit or induce SULT and UGT enzymes within 7 days before taking the study drug and cannot stop the use;\n* (7) If the subject cannot tolerate venipuncture and\u002For has a history of fainting or needle shock;\n* (8) If the subject has long-term excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) in the past; or if within 24 hours before the first administration of the study drug, the subject consumed any food or beverage that inhibits or induces liver metabolic enzymes (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides compounds); or if within 24 hours before the first administration of the study drug, the subject took any product containing alcohol;\n* (9) If the subject has consumed blood or had a large amount of bleeding (more than 450 mL) within 3 months before the first administration of the study drug, or plans to donate blood or blood components during or after the study;\n* (10) If the subject has donated blood or had a large amount of bleeding (more than 450 mL) within 3 months before the first administration of the study drug, or plans to donate blood or blood components during or after the study;\n* (11) If the subject has acute diseases during the screening stage of the study or before taking the study drug;\n* (12) If the subject has consumed foods or beverages that inhibit or induce liver metabolic enzymes within 24 hours before the first administration of the study drug (such as grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which contain rich flavonoids or citrus glycosides compounds);\n* (13) If the subject is pregnant or breastfeeding, and the subject (or their partner) has a pregnancy plan during and after the study, and does not agree to use non-drug measures for contraception during the study period;\n* (14) (Medical Inquiry) Those who underwent surgery within three months prior to the screening period, or those planning to undergo surgery during the study period, and those who have undergone surgeries that may affect drug absorption, distribution, metabolism, and excretion;\n* (15) Those with a history of drug use or drug abuse;\n* (16) Those who smoked more than 5 cigarettes per day within 14 days prior to the screening, or those who cannot stop using any tobacco products during the trial;\n* (17) Those who smoked or used any tobacco products during the screening to admission period;\n* (18) During the screening period, abnormalities in physical examination, electrocardiogram, and laboratory tests (including routine blood and urine tests, coagulation function, and pregnancy test for women of childbearing potential only) that are judged by the investigator as clinically significant (excluding those caused by renal insufficiency). For liver function tests: ALT \\> 3×ULN or AST \\> 3×ULN or T-BIL \\> 2×ULN or D-BIL \\> 2×ULN; for lipid tests: TG ≥ 5.6 mmol\u002FL; for serum electrolyte tests (K+, Na+, Cl-, Ca2+): abnormalities indicating hyperkalemia or a tendency toward acidosis (limited to patients with renal insufficiency).\n* (19) Those whose physical examination, vital sign measurement, electrocardiogram examination, laboratory tests \\[blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy (only for women of childbearing age)\\] as determined by the researchers show abnormal results with clinical significance; (for healthy subjects)\n* (20) Those with positive nicotine test results;\n* (21) Those with alcohol breath test results greater than 0.0 mg\u002F100 ml;\n* (22) Those with positive urine drug screening results;\n* (23) Those with positive hepatitis B surface antigen, or hepatitis C antibody, or syphilis spirochete antibody, or HIV antibody test results positive;\n* (24) Those who, as determined by the researchers, have any situation that may affect the subject's provision of informed consent or compliance with the trial protocol, or who participating in the trial may affect the trial results or their own safety.",true,"ALL","18 Years","70 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability.\n\nBased on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.",[28],"Renal Insufficiency Chronic",[30],"Hydroxynidone","RECRUITING","2026-08-11",{"date":34,"type":35},"2026-08-13","ACTUAL",{"date":37,"type":35},"2025-12-25",{"date":39,"type":22},"2026-12-01",{"name":41,"class":42},"Beijing Continent Pharmaceutical Co, Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100622827","phase-2-pirfenidone-capsules-in-the-treatment-of-radiation-induced-lung-injury-with-or-without-immune-pneumonia-100622827","NCT07388680","Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II\u002FIII Clinical Trial on the Efficacy and Safety of Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune-related Pneumonia","Inclusion Criteria:\n\n* The subjects must meet all the following inclusion criteria to be enrolled in this study:\n* Voluntary signing of the informed consent form, and being capable of understanding and signing the informed consent form before the study.\n* Age 18 to 75 years (inclusive of 18 and 75), with no gender restrictions.\n* Malignant tumors diagnosed by pathological histology\u002Fcytology, and having received radiotherapy to the chest.\n* According to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 standard, diagnosed by the investigator as clinical RILI grade 2-3 with or without CIP. For those with CIP, the investigator determines that only hormone treatment is required.\n* At the time of enrollment, 40% ≤ DLCO as a percentage of the predicted value \\\u003C 80% (mild to moderate lung diffusion function impairment).\n* The course of radiation-induced lung injury is less than 2 months.\n* If receiving radiation-induced lung injury-related treatment (including glucocorticoids, antibiotics, etc.) at the time of enrollment, the types and doses of medication must remain stable within 2 weeks before enrollment, and the hormone medication does not exceed 4 weeks.\n* At the time of enrollment, the investigator assesses that the subjects can take oral administration of the investigational drug.\n* Eastern Cooperative Oncology Group score (ECOG) 0-2.\n* Expected survival period ≥ 6 months.\n* The functional level of major organs meets the following standards:\n\n  1. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 75 × 109\u002FL or hemoglobin (Hb) ≥ 90 g\u002FL;\n  2. Biochemical examination: Total bilirubin (TBIL), blood urea nitrogen (BUN), and creatinine (Cr) ≤ 1.5 upper limit of normal value (ULN), or creatinine clearance rate ≥ 50 mL\u002Fmin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.0 ULN.\n\n     * Creatinine clearance rate = \\[(140 - age) × weight (kg)\\] \u002F \\[0.818 × Scr (umol\u002FL)\\] (for females × 0.85)\n* For all fertile women, the serum pregnancy test within 7 days before the first administration must be negative, and fertile male and female subjects must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) with their partners during the entire study period and at least 6 months after the last use of the investigational drug.\n\nExclusion Criteria:\n\n* Subjects with Child-Pugh grade C at the time of enrollment or with severe liver diseases such as liver failure, hepatic encephalopathy, etc.\n* Subjects who have had Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug eruption with eosinophilia and systemic symptoms (DRESS), or severe skin diseases in the past or currently;\n* Subjects who have other diseases that the investigator deems unsuitable for participation in this study during the screening process.\n* Subjects with active untreated brain metastases or meningeal metastases; for subjects with treated central nervous system (CNS) metastases, if the symptoms are controlled for at least 4 weeks, they are eligible for enrollment;\n* Subjects who have a second malignancy that requires concurrent systemic cytotoxic chemotherapy, investigational treatment or biological therapy (such as anti-cytotoxic T lymphocyte-associated protein 4 \\[CTLA4\\] or human epidermal growth factor receptor 2 \\[HER2\\] monoclonal antibodies), but are allowed to enroll if they have a second malignancy that only requires hormone therapy (such as gonadotropin-releasing hormone \\[LHRH\\] agonists, tamoxifen, etc.);\n* Subjects with a history of human immunodeficiency virus (HIV) infection, or positive HIV antibodies or suspected HIV infection.\n* Subjects who cannot discontinue tetracycline antibiotics (such as doxycycline, minocycline, etc.) within 14 days before screening or during the study.\n* Subjects who the investigator deems unable to follow the testing procedures (such as being unable to tolerate the interruption of assisted oxygen supply during pulmonary function tests).\n* Subjects who have used or are to use drugs that may have preventive and\u002For therapeutic effects on radiation pneumonitis within 1 month before screening or during the study, such as pentoxifylline, angiotensin-converting enzyme inhibitors, berberine, ursolic acid, statins, nicorandil, stem cells, interferon-γ, penicillamine, etc.;\n* Subjects who have used nintedanib or high-dose acetylcysteine within 1 month before randomization;\n* Subjects who have used known or judged by the investigator to be beneficial to lung injury Chinese herbal medicines or other substances during the 1 month before randomization;\n* Subjects who have received or been exposed to live vaccines or attenuated live vaccines or plan to receive live vaccines or attenuated live vaccines (except anti-tumor treatment live vaccines) during the study;\n* Subjects who have used drugs that are strong inhibitors or inducers of cytochrome CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 within 1 month before screening or during the study;\n* Female subjects who are breastfeeding at the time of screening or male subjects whose partner is planning to get pregnant during the study.\n* Subjects with known mental disorders that may affect the study assessment or with poor compliance.\n* Subjects who are allergic to any active ingredients of this drug or its excipients (such as lactose) or lactose intolerant.\n* Subjects who had severe trauma or received surgery within 1 month before screening or during the study, or who plan to undergo surgery during the study.\n* Subjects who, according to the investigator's judgment, have other serious systemic diseases or laboratory test abnormalities or other reasons that make them unsuitable for participating in this clinical trial.\n* Subjects who plan to participate in other drug clinical trials during the study.","75 Years",{"count":53,"type":22},298,[55,56],"PHASE2","PHASE3","Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II\u002FIII trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).",[59,60],"Radiation-induced Lung Injury","Immune-related Pneumonia",[62,63,64,65,66],"Radiation-induced lung injury","Immune-related pneumonia","RILI","CIP","Pirfenidone","2026-04-19",{"date":69,"type":35},"2026-04-22",{"date":71,"type":35},"2026-03-26",{"date":73,"type":22},"2026-12-30",{"name":41,"class":42},36,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":16,"sex":83,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":43},"100629172","phase-1-c-hydronidone-mass-balance-study-100629172","NCT07471217","[¹⁴C] Hydronidone Mass Balance Study","[¹⁴C] Hydronidone Mass Balance Study in Chinese Healthy Adult Male Participants","Inclusion Criteria:\n\n* Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;\n* Chinese adult male participants aged 18 to 50 years (inclusive);\n* Participants weighing at least 50 kg at screening, with a body mass index \\[BMI = weight (kg) \u002F height² (m²)\\] within the range of 19.0 to 26.0 kg\u002Fm² (inclusive);\n* Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.\n\nExclusion Criteria:\n\n* The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;\n* Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;\n* Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;\n* Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen\u002Fantibody;\n* Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except for appendectomy), or plans to undergo surgery during the trial period;\n* A previous diagnosis of Gilbert's syndrome;\n* Hemorrhoids with bloody stools or perianal diseases with regular or ongoing bloody stools; severe nausea or vomiting within one week before screening; habitual constipation or diarrhea; or positive fecal occult blood test;\n* Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days or 5 half-lives (whichever is longer) prior to dosing; use of strong inhibitors or inducers of UGTs, SULTs, CYP3A4, P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, or OAT1\u002F3, or any drugs known to prolong the QT\u002FQTc interval or carry a risk of causing torsade de pointes (TdP) within 4 weeks before screening (see Appendix 2 for details); or plans to use any chemical drugs, biologics, traditional Chinese medicines, or natural products during the trial that the researcher deems unsuitable;\n* A history of drug allergies or allergic diseases (such as asthma, urticaria, eczematous dermatitis), or a suspected or confirmed allergy to the trial drug (including similar drugs) or any of its excipients as determined by the researcher;\n* Participants with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;\n* Participation in any other clinical trial drug or interventional clinical study within 3 months before screening;\n* Blood donation or blood loss ≥ 400 mL within 3 months before dosing, or blood transfusion or use of blood products within 4 weeks before dosing;\n* Difficulty in blood collection or intolerance to venous blood sampling.\n* Individuals who work with long-term exposure to radioactive conditions, or those with significant radioactive exposure within 1 year prior to screening (≥2 chest\u002Fabdominal CT scans, or ≥3 other types of X-ray examinations), or those who have participated in radiolabeled drug trials within 1 year prior to screening;\n* History of drug abuse or substance abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine);\n* Average weekly alcohol consumption of ≥14 units within 3 months prior to screening (1 unit ≈ 360 mL beer, or 45 mL liquor, or 150 mL wine), or positive breath alcohol test;\n* Average daily smoking of \\>5 cigarettes (or equivalent nicotine products) within 3 months prior to dosing, or inability to discontinue any tobacco products during the study, or positive cotinine test;\n* Habitual consumption of grapefruit juice or excessive tea, coffee, and\u002For caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL), and inability to abstain during the study; or consumption of any chocolate, caffeine, or xanthine-rich foods or beverages within 48 hours prior to dosing;\n* Vaccination within 4 weeks prior to dosing, or planned vaccination within 1 month after dosing;\n* Other reasons deemed by the investigator as making the participant unsuitable for this study.","MALE","50 Years",{"count":86,"type":22},8,[25],"According to the \"Technical Guidelines for Radioactive Labeled Human Mass Balance Studies\" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a \\[¹⁴C\\] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.",[90],"Chronic Hepatitis B-related Liver Fibrosis",[92,93],"Chronic Hepatitis B-related liver fibrosis","Hydronidone","NOT_YET_RECRUITING","2026-03-10",{"date":97,"type":35},"2026-03-13",{"date":99,"type":22},"2026-04-30",{"date":101,"type":22},"2026-07-30",{"name":41,"class":42},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":43},"100585242","phase-1-preliminary-human-trials-of-f230-tablets-100585242","NCT06899815","Preliminary Human Trials of F230 Tablets","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of Single and Multiple Administration of F230 Tablets in Healthy Adult Volunteers","Inclusion Criteria:\n\nVolunteers must meet all of the following criteria to be selected:\n\n1. Healthy volunteers, half male and half female, should be replaced by volunteers of the same sex;\n2. Age: 18 \\~ 45 years old;\n3. Weight: male ≥50kg, female ≥45kg, 19≤BMI≤26 (BMI= weight (kg)\u002Fheight 2 (m2));\n4. Pass the comprehensive health examination: vital signs, physical examination, blood urine routine, blood pregnancy, blood glucose, blood lipid, blood electrolyte, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, 12-lead electrocardiogram, nicotine, urine drug screening, alcohol breath test, abdominal B-ultrasound, chest X-ray examination, etc., no abnormalities or abnormalities have no clinical significance;\n5. Before participating in the study, have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participate in this clinical trial, can communicate well with the investigators, comply with the requirements of the entire study, and have the ability to understand and sign the written informed consent.\n\nExclusion Criteria:\n\n* Volunteers who meet one of the following conditions are not eligible for this study:\n\n  1. Participants in any other clinical trial within three months prior to the trial;\n  2. Serum ALT \\> upper limit of normal (ULN), AST \\> Upper limit of normal (ULN), TBil \\> upper limit of normal (ULN);\n  3. (Inquiry) Are there any underlying liver diseases, such as chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, moderate to severe non-alcoholic fatty liver disease, liver cirrhosis, etc.;\n  4. (Consultation) Have any disease that may affect the safety of the trial or the process of the drug in vivo, including but not limited to: Heart, liver, kidney, endocrine, digestive, immune, respiratory, nervous or psychiatric systems, or other pre-existing or existing diseases of the above systems \\[especially cardiovascular disease including those at risk for cardiovascular disease, any gastrointestinal disease that interferes with drug absorption (e.g. symptoms of irritable bowel syndrome, history of inflammatory bowel disease), active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, epilepsy, etc. Sensitive rhinitis, eczematous dermatitis, asthma, active pulmonary tuberculosis, etc.\n  5. (Consultation) Allergy: If there is a history of drug, food allergy or skin allergy;\n  6. (Interview) Any drug that inhibits or induces liver metabolism of the drug in the 28 days prior to the use of the study drug (common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, grofulvin, methylaminopropyl, phenytoin, Grumette, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);","45 Years",{"count":112,"type":22},136,[25],"F230 is a new Class 1 chemical drug jointly developed by Beijing Contini Pharmaceutical Co., Ltd. for the treatment of pulmonary hypertension (Notification number: 2024LP01242, 2024LP01243). The in vitro activity and in vivo toxicology tests of F230, the lead compound for the treatment of PAH developed by Beijing Contini Pharmaceutical Co., LTD., showed that F230 had the same in vitro activity as the endothelin antagonist on the market. The pharmacodynamics of F230 in rats with nephrogenic hypertension induced by Sunitinib showed that F230 could reduce proteinuria and improve renal index.It is expected to bring higher treatment and survival benefits to the corresponding patients. According to the spirit of NMPA new drug approval, on the basis of the completion of preclinical studies of this drug, the safety, tolerability and pharmacokinetic characteristics of single administration and multiple administration of this drug in healthy volunteers should be investigated first, and the influence of food on the pharmacokinetic characteristics of F230 in humans should be investigated, so as to recommend a safe and effective administration regimen for phase II clinical trials.",[116],"Pulmonary Hypertension",[118,119],"Pulmonary hypertension","F230","2026-03-09",{"date":122,"type":35},"2026-03-11",{"date":124,"type":35},"2025-05-15",{"date":126,"type":22},"2026-07-01",{"name":41,"class":42},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100624638","phase-3-a-phase-iiic-clinical-study-to-evaluate-the-long-term-treatment-of-hydronidone-capsules-for-liver-fibrosis-in-patients-with-chronic-hepatitis-b-100624638","NCT07412236","A Phase IIIc Clinical Study to Evaluate the Long-term Treatment of Hydronidone Capsules for Liver Fibrosis in Patients With Chronic Hepatitis B.","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIIc Clinical Study Evaluating the Long-term Treatment of Hepatic Fibrosis in Chronic Hepatitis B With Hydronidone Capsules.","Inclusion Criteria:\n\n* Age 18 to 65 years (inclusive of 18 and 65 years old at the time of signing the informed consent form), male or female;\n* Documented history of chronic hepatitis B and\u002For positive for hepatitis B surface antigen (HBsAg) for ≥6 months;\n* Treatment-naïve or treatment-experienced patients with chronic hepatitis B, defined as follows:\n\n  1. Treatment-naïve patients must meet all of the following criteria:\n\n     * No prior systemic antiviral therapy (e.g., interferon and\u002For nucleos(t)ide analogues) before randomization;\n     * Positive for HBV DNA;\n     * Liver stiffness measurement (LSM) by transient elastography ≥12.4 kPa for treatment-naïve patients with ALT \\>2 × ULN; or LSM ≥10.6 kPa for treatment-naïve patients with ALT ≤2 × ULN. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n  2. Treatment-experienced patients must meet all of the following criteria:\n\n     * A history of ≥6 months of continuous nucleos(t)ide analogue therapy for hepatitis B up to randomization, currently receiving monotherapy with a nucleos(t)ide analogue \\[e.g., Tenofovir Alafenamide Fumarate (TAF), Tenofovir Disoproxil Fumarate (TDF), or Entecavir (ETV)\\];\n     * HBV DNA positive or negative is acceptable;\n     * Liver stiffness measurement (LSM) by transient elastography \\>9.0 kPa. Subjects whose LSM does not meet the above criteria may still be enrolled if they have liver biopsy evidence (within the past 6 months) confirming liver fibrosis of Ishak score ≥3.\n* ALT \\\u003C8 × ULN;\n* No use within 3 months prior to randomization of the following Chinese patent medicines that may have antifibrotic effects: Fuzhenghuayu Capsule (Tablet), Anluohuaxian Pill, Compound Biejia Ruangan Tablet, etc.;\n* Subjects (or their sexual partners) have no pregnancy plan during the trial and for 6 months after trial completion, voluntarily agree to use effective physical contraceptive methods, and have no plan to donate sperm or eggs;\n* Subjects have fully understood the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to participation, voluntarily agree to take part in this clinical trial, are able to communicate well with the investigators, agree to comply with all study requirements, and have provided written informed consent.\n\nExclusion Criteria:\n\n* Total bilirubin (TBil) \\>3 × ULN, or 3 × ULN \\\u003C ALT \\\u003C8 × ULN with TBil \\>2 × ULN;\n* Platelet count (PLT) ≤50 × 10⁹\u002FL;\n* Prothrombin activity (PTA) \\\u003C50% or International Normalized Ratio (INR) \\>1.5;\n* Imaging findings suggestive of a space-occupying lesion in the liver indicative of tumor, or alpha-fetoprotein (AFP) \\>100 μg\u002FL even in the absence of specific signs of hepatocellular carcinoma;\n* Patients with decompensated liver cirrhosis (complications including ascites, esophageal and\u002For gastric variceal bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis, and cirrhotic cardiomyopathy) or with hepatic malignancy;\n* Patients with chronic hepatitis C or non-viral chronic hepatitis (alcoholic, drug-induced, etc., excluding metabolic dysfunction-associated steatotic liver disease (MASLD));\n* History of alcohol abuse or inability to abstain from alcohol recently \\[Note: Alcohol abuse is defined as: ① daily ethanol consumption ≥40 g for males or ≥20 g for females for 5 consecutive years; OR ② history of heavy alcohol consumption (\\>80 g of ethanol per day) within the past 2 weeks. Ethanol (g) = volume of alcoholic beverage consumed (mL) × alcohol by volume (%) × 0.8\\];\n* Patients with severe concurrent cardiovascular, pulmonary, renal, endocrine, neurological, or hematological diseases, or psychiatric disorders;\n* Pregnant and\u002For lactating women;\n* Participation in any other drug clinical trial within the past 3 months;\n* Any condition that, in the investigator's judgment, may affect the subject's ability to provide informed consent or comply with the trial protocol, or participation that may affect the trial results or the subject's own safety.","65 Years",{"count":137,"type":22},1208,[56],"This study is conducted as a randomized, double-blind, placebo-controlled, multicenter clinical trial on a background of entecavir therapy. It aims to evaluate the clinical benefits of Hydronidone Capsules in patients with liver fibrosis due to chronic hepatitis B. The study consists of a Screening\u002FBaseline Period (4 weeks) and a Dosing\u002FObservation Period (planned duration of 5 years, including a 52-week primary treatment phase and a 208-week long-term treatment phase).",[141,142],"Liver Fibrosis","Liver Fibrosis in Chronic Hepatitis B",[144],"LIver Fibrosis in Chronic Hepatitis B","2026-02-12",{"date":147,"type":35},"2026-02-17",{"date":149,"type":22},"2026-01-30",{"date":151,"type":22},"2028-12-30",{"name":41,"class":42},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":43},"100613112","phase-1-the-phase-d-clinical-trial-of-hydronidone-capsules-100613112","NCT07262346","The Phase Ⅰd Clinical Trial of Hydronidone Capsules","Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)","Inclusion Criteria:\n\n1. Healthy subjects, both male and female;\n2. Age: 18-45 years;\n3. Weight: Male ≥50 kg, Female ≥45 kg, with a BMI between 19 and 26 (BMI = weight (kg)\u002Fheight² (m²));\n4. Pass a comprehensive health examination, meaning no abnormalities or no clinically significant findings in the following: vital signs, physical examination, blood and urine routine tests, blood pregnancy test, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody tests, 12-lead electrocardiogram, nicotine screening, urine drug screening, alcohol breath test, chest X-ray, etc.;\n5. Have been fully informed about the nature, significance, potential benefits, possible inconveniences, and risks of the study prior to participation, and voluntarily agree to take part in this clinical trial. Subjects must be able to communicate well with the researchers, comply with all study requirements, and have the capacity to understand and sign the written informed consent form.\n\nExclusion Criteria:\n\n1. (Inquiry) Participation in any other clinical trial within three months prior to this study;\n2. (Inquiry) Presence of any disease that may affect the safety of the trial or the pharmacokinetics of the drug, including but not limited to: past or current diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, nervous system, or psychiatric disorders \\[particularly cardiovascular diseases or individuals at risk of cardiovascular diseases, any gastrointestinal diseases affecting drug absorption (e.g., irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (e.g., peptic ulcer), urticaria, epilepsy, allergic rhinitis, eczematous dermatitis, asthma, active tuberculosis, etc.\\];\n3. (Inquiry) Allergic constitution: such as a history of drug or food allergies, skin allergies, or lactose intolerance;\n4. (Inquiry) Use of any drugs that inhibit or induce hepatic drug metabolism within 28 days before taking the investigational drug (common enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminoglutethimide, griseofulvin, meprobamate, phenytoin, glutethimide, rifampicin, dexamethasone; common enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides);\n5. Use of any medications (including herbal medicines) or health products within 14 days before the first dose;\n6. (Inquiry) Individuals with special dietary requirements who cannot adhere to a standardized diet (e.g., intolerance to standard meals) or those with difficulty swallowing;\n7. (Inquiry) Inability to tolerate venipuncture and\u002For a history of blood or needle phobia;\n8. (Inquiry) Habitual excessive consumption of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL); or consumption of any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) within 48 hours before the first dose, or adherence to any special diet that may affect drug absorption, distribution, metabolism, or excretion;\n9. (Inquiry) History of excessive alcohol consumption (defined as more than 28 standard units per week for men and more than 21 standard units per week for women (1 standard unit contains 14 g of alcohol, equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine)); or regular alcohol consumption (more than 14 standard units per week) within 6 months prior to the trial; or consumption of any alcohol-containing products within 24 hours before the first dose;\n10. (Inquiry) Blood donation or significant blood loss (exceeding 450 mL) within 3 months before the first dose, or plans to donate blood or blood components during the study or within 3 months after its completion;\n11. (Inquiry) Occurrence of an acute illness during the pre-study screening phase or before administration of the study drug;\n12. (Inquiry) Consumption of any foods or beverages known to induce or inhibit hepatic metabolic enzymes (e.g., grapefruit, mango, dragon fruit, grape juice, orange juice, etc., which are rich in flavonoids or citrus glycosides) within 24 hours before the first dose;\n13. (Inquiry) Surgery within three months before screening or plans to undergo surgery during the study period;\n14. (Inquiry) History of drug abuse or substance abuse;\n15. (Inquiry) Smoking more than 5 cigarettes per day within 14 days before screening, or inability to discontinue the use of any tobacco products during the trial period;\n16. (Inquiry) Smoking or use of any tobacco products between screening and hospital admission;\n17. Positive nicotine test result;\n18. Alcohol breath test result greater than 0.0 mg\u002F100 mL;\n19. Positive urine drug screen result;\n20. Pregnant or breastfeeding women;\n21. Individuals planning to conceive within 6 months after the trial or unwilling to use non-pharmacological contraceptive measures;\n22. Any condition deemed by the investigator as potentially affecting the subject's ability to provide informed consent, comply with the trial protocol, or participate in the trial in a way that could impact the results or subject safety.",{"count":161,"type":22},138,[25],"Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg\u002Fcapsule) in healthy subjects, in preparation for future expansion of indications.",[141],[93],"2025-11-21",{"date":168,"type":35},"2025-12-03",{"date":170,"type":22},"2025-12-05",{"date":172,"type":22},"2026-05-05",{"name":41,"class":42},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":43},"100461402","phase-3-efficacy-and-safety-of-pirfenidone-capsules-in-the-treatment-of-pneumoconiosis-100461402","NCT05288179","Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis","A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis","Inclusion Criteria:\n\n* 1\\. Age 18\\~70 years old (including 18 years old and 70 years old), gender is not limited.\n\n  2\\. Diagnosed with silicosis or coal worker's pneumoconiosis, in line with GBZ 70-2015 \"Diagnosis of Occupational Pneumoconiosis\".\n\n  3\\. Forced vital capacity at screening percentage of predicted value %FVC≥40% and \\\u003C80% 4. The percentage of carbon monoxide dispersion in the predicted value at the time of screening %DLCO≥30% and \\\u003C80%.\n\n  5.HRCT at screening showed diffuse interstitial changes in the lungs. 6. Patients voluntarily participated in this trial, with good compliance, and had the ability to understand and sign informed consent before the study.\n\nExclusion Criteria:\n\n* 1\\. Those who do not meet any of the inclusion criteria. 2. Those who have received lung lavage therapy within 3 months and plan to receive lung lavage therapy during the trial.\n\n  3\\. ALT or AST \\> 3 times ULN. 4. TBiL \\> 2 times ULN. 5. Creatinine clearance \\\u003C30 mL\u002Fmin. 6. Patients with co-infection or high fever within 4 weeks prior to screening, including but not limited to acute bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis.\n\n  7\\. Combined with tuberculosis or lung cancer. 8. Significant pulmonary arterial hypertension requiring parenteral therapy with epoprostenol\u002Ftreprostinil or severe right heart failure determined by the investigator to be unsuitable to participate in the trial.\n\n  9\\. Severe cardiovascular disease with one of the following conditions:\n  1. Severe hypertension within 6 weeks and uncontrolled with treatment (≥160\u002F100 mmHg);\n  2. Myocardial infarction within 6 months;\n  3. Unstable angina within 6 months. 10. Coagulation parameters: International normalized ratio (INR) \\> 2, prothrombin time (PT) prolongation \\> 1.5 times ULN.\n\n     11\\. Other conditions or comorbidities that may interfere with testing procedures (eg, intolerance to interruption of supplemental oxygen during pulmonary function tests) or, based on the investigator's judgment, that may interfere with trial participation or that may put patients at risk.\n\n     12\\. Patients with dysphagia or clinical signs of malabsorption or who require parenteral nutrition.\n\n     13\\. With active peptic ulcer. 14. History of thrombotic events (including stroke and transient ischemic attack) within 12 months.\n\n     15\\. Use of cytotoxic drugs, immunosuppressive drugs, cytokine-modulating drugs, or receptor antagonist drugs such as azathioprine, cyclophosphamide, cyclosporine, etanercept, infliximab, white Triene antagonists, methotrexate, tacrolimus, TNF-α inhibitors and tyrosine kinase inhibitors TKIs and other drugs.\n\n     16\\. Use of interferon, bisbenzylisoquinoline alkaloids (tetrandrine), polyethylene pyrimidine nitroxide (gramsilpine), quinape phosphate, hydroxyquinoline phosphate, aluminum citrate within 1 month before randomization , nintedanib, or high-dose acetylcysteine.\n\n     17\\. Patients who have previously used drugs that may cause pulmonary fibrosis, such as amiodarone, or have been exposed to asbestos, beryllium and other substances, or exposed to radioactive environments.\n\n     18\\. Hypersensitivity to the investigational drug or its components (eg, lactose).\n\n     19\\. Investigator judges that life expectancy due to other medical conditions is \\\u003C 2.5 years.\n\n     20\\. Major surgery planned during treatment. 21. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial.\n\n     22\\. Women of childbearing age who are unwilling or unable to use a highly effective method of contraception during the 28 days before or 3 months after dosing.\n\n     23\\. According to the researcher, the patient is either alcohol or drug abuser. 24. mentally ill. 25. Those who participated in clinical trials of other drugs within 3 months. 26. Investigators judged to be unfit to participate in the trial.",{"count":182,"type":22},272,[56],"This study is a randomized, double-blind, placebo-controlled, multicenter clinical study.\n\nThe main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.",[186],"Pneumoconiosis","2025-11-19",{"date":189,"type":35},"2025-11-24",{"date":191,"type":35},"2022-06-07",{"date":193,"type":22},"2026-09-30",{"name":41,"class":42},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},"100492246","phase-2-f573-for-injection-for-the-treatment-of-liver-injuryfailure-100492246","NCT05689645","F573 for Injection for the Treatment of Liver Injury\u002FFailure","F573 for Injection for the Treatment of Liver Injury\u002FFailure : Randomized, Double-blind, Placebo-controlled Phase Ⅱa Clinical Trial","Inclusion Criteria:\n\n（1）The first stage:\n\nParticipants who meet all of the following criteria will be enrolled in the study:\n\n1. Age ≥18 and ≤60 years old, gender is not limited;\n2. Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the \"Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)\"). Screening patients with CHB may provide etiological (HBsAg positive and\u002For HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.\n3. Serum ALT: 2\\~ 10× upper limit of normal (ULN), TBil: \\\u003C5×ULN;\n4. DILI patients: the abnormal duration of liver biochemical indexes \\[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\\] does not exceed 90 days;\n5. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;\n6. Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n(2)The second stage:\n\nSubjects meeting all of the following criteria will be included in the study:\n\n1. Age ≥ 18 and ≤ 65 years old, with no gender restrictions;\n2. According to the \"Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition)\", patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;\n\n   1. Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \\> 3 times the upper limit of normal (ULN), and TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;\n   2. Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \\> 2 times the ULN (the ULN of TBil refers to 17.1 μmol\u002FL); ② ALP \\> 1.5 times the ULN; ③ALT\\>1×ULN;\n3. The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;\n4. They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.\n\nThe third stage:\n\nSubjects who meet all of the following criteria will be enrolled in the study:\n\n1\\. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the \"Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition)\" may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.\n\n\\-\n\nExclusion Criteria:\n\nThe first stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. According to the investigator's judgment, the subjects were patients with cholestatic liver injury;\n2. Previous diagnosis of cirrhosis or liver hardness determination (LSM) at screening ≥ 12.4kPa;\n3. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases, and patients with malignant tumors;\n4. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C75× 109\u002FL, hemoglobin (HGB) \\\u003C90 g\u002FL;\n   2. Prothrombin activity \\\u003C40%, prothrombin time (PT) extended \\>5 s;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n5. Allergic or intolerant to the investigational drug, or allergic;\n6. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n7. Poor compliance can not partner;\n8. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n9. Participants in other clinical trials within 3 months;\n10. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe second stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. The diagnosis is advanced liver cirrhosis (with complications such as ascites and hepatic encephalopathy), or liver cancer, or when liver stiffness measurement (LSM) is ≥ 18.0 kPa during screening.\n2. Patients with severe or life-threatening heart, lung, brain, kidney, gastrointestinal and systemic diseases are malignantTumor patients;\n3. There are the following laboratory test values or abnormal test values:\n\n   1. Blood routine: platelet (PLT) \\\u003C100×109\u002FL, hemoglobin (HGB) \\\u003C100 g\u002FL;\n   2. INR\\>1.4, or as determined by the investigator to meet the criteria for severe hepatitis;\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Allergic or intolerant to the investigational drug, or allergic;\n5. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n6. Poor compliance can not partner;\n7. Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n8. Participants in other clinical trials within 3 months;\n9. Patients who had used liver protection drugs other than ursodeoxycholic acid or adenosylmethionine and basic therapeutic drugs (polyene phosphatidylcholines and glutathione drugs) within 3 days before randomization;\n10. Patients who had used glucocorticoids or interferon drugs within 3 days before randomization;\n11. The researcher considers any circumstances unsuitable for inclusion.\n\nThe third stage:\n\nSubjects meeting one of the following conditions will not be included in the trial:\n\n1. Patients who have completed liver transplantation or plan to undergo liver transplantation within 1 month;\n2. Severe grade 3 ascites or stubborn ascites;\n3. Patients with ≥ grade 3 hepatic encephalopathy;\n4. Patients who received artificial liver treatment within 1 week before screening;\n5. Patients with severe underlying diseases, such as respiratory system, digestive system, circulatory system, endocrine and other diseases and malignant tumors, and patients with severe infections that cannot be controlled by drugs;\n6. During the screening period or within 1 month before screening, the results of gastroscopy or imaging (abdominal B-ultrasound, CT or MRI) examination suggest severe varicose veins with bleeding risk;\n7. Patients with acute kidney injury (AKI), defined as meeting one of the following conditions:\n\n   1. Serum creatinine (Scr) increased ≥26.5 μmol\u002FL (0.3 mg\u002FdL, 1 mg\u002FdL=88.4 μmol\u002FL) within 48 h;\n   2. The Scr increase exceeds 1.5 times or more of the base value within 7 days;\n   3. Decreased urine volume (\\\u003C0.5 mL\u002Fkg\u002Fh) for more than 6 hours;\n8. Allergic or intolerant to the investigational drug, or allergic;\n9. The subject is unable to express his main complaint, such as mental illness and severe neurosis;\n10. Poor compliance can not partner; 11 Pregnant women, breastfeeding women or women of childbearing age who are trying to conceive;\n\n12\\. Participants in other clinical trials within 3 months; 13. The researcher considers any circumstances unsuitable for inclusion.","60 Years",{"count":204,"type":22},97,[55],"This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial .\n\nThe primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury (DILI), chronic hepatitis B (CHB), intrahepatic cholestatic liver injury, etc.).",[208,209],"Acute Liver Failure","Acute-On-Chronic Liver Failure",[211],"F573 for injection Liver Injury\u002FFailure","2025-11-17",{"date":187,"type":35},{"date":215,"type":35},"2023-03-24",{"date":217,"type":22},"2026-09-01",{"name":41,"class":42},10,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":135,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100508803","phase-3-hydronidone-capsules-in-long-term-treatment-in-patients-with-chronic-viral-hepatitis-b-liver-fibrosis-100508803","NCT05905172","Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis","A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B","Inclusion Criteria:\n\n* Participate in the Phase III trial of this project (Protocol Number: KDN-F351- 202101 ，ClinicalTrials.gov ID: NCT05115942 ), complete the main treatment course and the last visit;\n* Before the trial, the subject understood the nature, significance, possible benefits, possible inconvenience and potential dangers of the trial, volunteered to participate in the clinical trial, was able to communicate well with the investigator, comply with the requirements of the whole study, and signed a written informed consent.\n\nExclusion Criteria:\n\n* One of any clinical endpoints occurred during the phase III trial (Note: for non cirrhotic patients, Clinical endpoints include progression to cirrhosis,decompensated cirrhosis complications \\[ascites, esophagogastric vein rupture and bleeding, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome, hepatic encephalopathy, portal vein thrombosis and cirrhotic cardiomyopathy\\], hepatocellular carcinoma, liver transplantation or liver disease related death \u002F all-cause death; For patients with liver cirrhosis, Clinical endpoints include complications of decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, or liver disease-related death \u002F all-cause death);\n* Patients with malignant tumors other than hepatocellular carcinoma and with an expected survival period of less than 1 year;\n* Any opinion of the investigator that may affect the subject to provide informed consent or follow the trial protocol, or participation in the trial may affect the trial results or their own safety.",{"count":228,"type":22},248,[56],"This study is a Phase IIIb extension trial following the \"A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase III Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B\".\n\nThe main objective of this study is to evaluate the effectiveness and the safety of hydronidone capsules for long-term treatment of patients with chronic viral hepatitis B liver fibrosis.",[141],"2025-05-30",{"date":234,"type":35},"2025-06-04",{"date":236,"type":35},"2023-08-12",{"date":238,"type":22},"2028-10-20",{"name":41,"class":42},23,""]