[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-b-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-b-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100648881","hepatitis-b-infection-surveillance-100648881",false,"NCT07727187","Hepatitis B Infection Surveillance","National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert\u002FReference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)","HEPB-SURVEY","Inclusion Criteria:\n\n* Age 18 years or older\n* Chronic HBsAg carriage\n* First referral to participating expert\u002Freference hepatology centers or hepatology\u002Finfectious diseases departments\n* Written informed consent obtained\n* Affiliation with national health insurance system or equivalent coverage\n\nExclusion Criteria:\n\n* Telephone-only referrals or medical record-only consultations\n* Telemedicine-only consultations\n* Inability or unwillingness to comply with study procedures\n* Inability to understand study objectives or procedures\n* Individuals deprived of liberty, under guardianship or under conservatorship","ALL","18 Years",{"count":20,"type":21},1360,"ESTIMATED","OBSERVATIONAL","France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive individuals, of whom 82% were unaware of their infection. Data on hepatitis D virus (HDV) infection remain limited; however, available studies suggest a prevalence of 6% to 10% among HBsAg-positive individuals. Despite current guideline recommendations, up to 35% of newly diagnosed HBsAg-positive patients between 2018 and 2022 were not screened for HDV infection.\n\nThe World Health Organization (WHO) targets for 2030 include a 90% reduction in the incidence of chronic viral hepatitis, a 65% reduction in hepatitis-related mortality, and treatment coverage for 80% of eligible diagnosed individuals. Achieving these goals will require strengthening HBV and HDV screening strategies and improving linkage to care and retention throughout the care cascade.\n\nObjectives: The primary objective is to assess the severity of liver disease, including significant fibrosis (≥F2) and cirrhosis (F4), among adults newly diagnosed with chronic HBV infection (with or without HDV infection) at Expert\u002FReference Hepatology Centers and Hepatology or Infectious Diseases Departments.\n\nThe secondary objectives are to:\n\n1. Describe demographic and virological characteristics of HBsAg-positive patients;\n2. Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;\n3. Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;\n4. Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;\n5. Compare clinical and virological characteristics of HBV-monoinfected and HBV\u002FHDV-coinfected patients;\n6. Identify molecular signatures associated with liver disease severity;\n7. Compare findings with those of a national cohort conducted 15 years earlier;\n8. Collect biological samples for future analyses;\n9. Assess the clinical utility of a highly sensitive HBcrAg assay. Method: This is a multicenter, observational study including all adults aged ≥18 years with chronic HBV infection, whether managed as outpatients or inpatients, who are newly referred to Expert\u002FReference Hepatology Centers or to Hepatology or Infectious Diseases Departments.\n\nConclusions: This study will generate updated national data on liver disease severity, treatment eligibility, and virological characteristics among adults newly diagnosed with chronic HBV infection in France.",[25],"Chronic Hepatitis B Infection",[27,28,29,30,31,32,33],"Hepatitis B","Chronic HBV infection","Hepatitis D","HBV","HDV","Liver fibrosis","Antiviral treatment","NOT_YET_RECRUITING","2026-07-21",{"date":37,"type":38},"2026-07-27","ACTUAL",{"date":40,"type":21},"2026-09-01",{"date":42,"type":21},"2029-09-01",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100632248","phase-1-a-phase-i-clinical-study-of-ahb---171-in-healthy-participantshp-and-chronic-hepatitis-b-chb-participants-100632248","NCT07511218","A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AHB - 171 Injection in Healthy Participants (HP) and Chronic Hepatitis B(CHB) Participants","Inclusion Criteria:\n\n* Healthy Participants:\n* Male or female participants, aged 18-55 years old (inclusive);\n* Body mass index between 18.0 and 28.0 kg\u002Fm\\^2 (inclusive);\n* Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance;\n* Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug.\n* Male participants must agree to use highly effective contraceptive methods (to ensure effective contraception for their female partners of childbearing potential) and refrain from donating sperm from screening until 6 months after the last dose of the study drug. Liver and kidney function tests meet the requirements at the time of screening.\n* CHB Participants:\n* Male or female participants, aged 18-65 years old (inclusive);\n* Body mass index between 18.0 and 32.0 kg\u002Fm\\^2 (inclusive);\n* Participants who take effective contraceptive measures as required;\n* HBsAg \\> 100 IU\u002FmL and ≤ 3000 IU\u002FmL, and HBV DNA \\\u003C 100 IU\u002FmL at screening.\n* Have received stable treatment with NA for at least 6 months and stable on the same NA for at least 3 months before screening.\n\nExclusion Criteria:\n\n* Healthy Participants:\n* Currently participating in another study, or within 5 half-lives\u002F3 months of the last dose of a previous investigational product.\n* Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.\n* Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.\n* Allergy to any investigational drug component.\n* Heavy Smoking (\\> 5 cigarettes\u002Fday); history of drug\u002Falcohol abuse; consumption of caffeine or alcohol within 48 hours before dosing.\n* Blood donation\u002Floss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.\n* Abdominal skin issues that may affect drug injection\u002Fobservation.\n* Positive for HBV, HCV, HIV, or syphilis.\n* Clinically significant ECG abnormality or TdP risk factors.\n* Any condition judged unsuitable by investigator.\n* CHB Participants:\n* Currently participating in another study, or within 5 half-lives\u002F3 months of the last dose of a previous investigational product.\n* Presence of ascites, gastrointestinal bleeding, hepatic encephalopathy, or varices.\n* History or suspicion of hepatocellular carcinoma (HCC); AFP \\> 50 ng\u002FmL.\n* Diagnosed or Suspected cirrhosis within 12 months.\n* History of transplantation, autoimmune diseases, or severe systemic diseases (besides chronic HBV).\n* Use of ASO, siRNA (oligonucleotide therapies), or interferon within 12 months.\n* Major injury\u002Fsurgery within 6 months, planned surgery during study, or acute infection within 14 days.\n* Allergy to any investigational drug component.\n* Blood donation\u002Floss ≥400 mL or transfusion within 12 weeks, or plan to donate during study.\n* Abdominal skin issues that may affect drug injection\u002Fobservation.\n* Key laboratory result not suitable for clinical trial.\n* HIV, HCV, or active syphilis infection; uncured hepatitis A, D, or E.\n* Clinically significant ECG abnormality or TdP risk factors.\n* Any condition judged unsuitable by investigator.",true,"65 Years",{"count":57,"type":21},110,"INTERVENTIONAL",[60],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.",[25],[64],"Hepatitis B, Chronic","RECRUITING","2026-07-20",{"date":35,"type":38},{"date":69,"type":38},"2026-04-13",{"date":71,"type":21},"2028-06-30",{"name":73,"class":74},"Ausper Biopharma Co., Ltd.","INDUSTRY",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":54,"sex":83,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":58,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":46},"100597508","phase-1-a-study-of-sn2001-dose-safety--immunogenicity-in-healthy-adults-100597508","NCT07059403","A Study of SN2001 Dose, Safety & Immunogenicity in Healthy Adults","A Phase I, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of SN2001 in Healthy Adult Subjects","Inclusion Criteria:\n\n1. Age 18 to 55 years, inclusive.\n2. Body mass index (BMI) ≥18.0 kg\u002Fm2 and ≤ 32.0 kg\u002Fm2.\n3. Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests.\n4. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral ovariectomy or post-menopause. A postmenopausal state should be confirmed by at least 12 months since last menstrual period and FSH \\> 40 IU.\n5. Women of childbearing potential (WOCBP) may be enrolled in the study if the participant:\n\n   * has practiced highly-effective contraception for 28 days prior to first injection, and\n   * has a negative pregnancy test at Screening, and\n   * agrees to refrain from ova donation from Screening until 48 weeks after completion of the final injection, and\n   * practices abstinence as part of her usual and preferred lifestyle, and\n   * has agreed to continue highly-effective contraception from Screening until 48 weeks after completion of the final injection.\n6. Male participants:\n\n   * with documented bilateral orchiectomy, or\n   * agrees to practice abstinence from penile-vaginal intercourse or use condoms from Screening until 48 weeks after completion of the final subcutaneous injection, and\n   * agrees to refrain from sperm donation from Screening until 48 weeks after completion of the final injection, and\n   * the highly effective contraceptive methods listed above should also apply to WOCBP partners of male participants for the specified duration, in addition to male condom use, from Screening until 48 weeks after completion of the final injection.\n7. Willing to comply with the study requirements and to provide written informed consent.\n\nExclusion Criteria:\n\n1. History of Hepatitis B virus (HBV) infection as evidenced by detection of HBV Surface and Core antigens.\n2. Clinical laboratory evidence of active infection with human immunodeficiency virus (HIV) infection, or hepatitis C virus (HCV) infection, or hepatitis A virus (HAV), or hepatitis D virus (HDV), or syphilis and\u002For any other chronic viral infection.\n3. Known exposure (e.g., sexual contact or blood exposure) to HBV within the past 6 weeks.\n4. History of HBV vaccination:\n\n   * Have not previously been vaccinated in the community for Hepatitis B (Engerix-B or similar), or\n   * Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) and a seroprotective Hepatitis B surface antibody (HBsAb) titre \\\u003C10 milli-international units per milliliter (mIU\u002FmL) at screening, or\n   * Have received any HBV vaccination (documented evidence of vaccination, or verbal history of vaccination) within 6 months prior to the screening visit, or\n   * Have HBV vaccination scheduled plan within 48 weeks after the final study drug dosing.\n5. Receipt of any investigational drug or vaccine or medical device clinical trial within 3 months or 5 half-lives (whichever is greater) prior to screening.\n6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin greater than or equal to 1.5×ULN, or any other laboratory values considered clinically significant abnormalities and unacceptable by the Investigator at screening.\n7. Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or renal disease (such as chronic liver disease), gastrointestinal tract disease, respiratory disease, metabolism, skeletal system diseases or other conditions known to put the subject at significant risk.\n8. History of Cancer within 3 years, excluding basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia, which is cured is allowed.\n9. Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus.\n10. History of any severe trauma or major surgical condition within 3 months or planned to undergo surgery during the study period.\n11. Presently receiving (or history of receiving), during the preceding 3 months or 5 half-lives (whichever is greater), any medications or other treatments that may adversely affect the immune system such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids, intranasal corticosteroids (e.g. Nasonex for allergic rhinitis) are allowed.\n12. Used prescription drugs or vaccines within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.\n13. Used over-the-counter (OTC) medication or herbal supplements, excluding routine vitamins, within 7 days before the first dose of study drug, unless determined by the Investigator and the Sponsor to be not clinically relevant and unlikely to impact on study outcomes. Paracetamol or ibuprofen can be considered an exception for the treatment of headaches or any other pain for eligibility purposes.\n14. Participants smoke ≥ 10 cigarettes a day within 3 months before screening, or those who cannot stop using any tobacco products from screening until 24 weeks after the final injection.\n15. History or clinical evidence of alcohol abuse, within the 3 months before screening, and unwillingness to abstain from alcohol within 3 weeks after the final study drug dosing. Alcohol abuse is defined as regular weekly intake of more than 14 units for male and 10 units for female (unit: 1 glass of wine \\[125 mL\\] = 1 measure of spirits = ½ pint of beer).\n16. History or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and\u002For chronic use of drugs or other substances with or without problems related to their use and\u002For were stopping or a reduction in dose will lead to withdrawal symptoms.\n17. Confirmed positive results from drug of abuse (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, tetrahydrocannabinol, cotinine, tricyclic anti-depressants) or from the alcohol breath test at screening.\n18. History of significant local or systemic reactogenicity (e.g., anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or ulceration).\n19. Donated more than 400 mL of blood within 30 days before the first dose of study drug.\n20. Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.","MALE","55 Years",{"count":86,"type":21},36,[60],"This is a randomized, double-blind, placebo-controlled, multiple-ascending-dose study of SN2001 in healthy adult subjects. The study is designed to evaluate the safety, tolerability and immunogenicity of SN2001.",[25],[91,92,93,94],"SN2001","Chronic hepatitis B infection (CHB)","Hepatitis B infection (HBV)","Healthy Adult Subjects","2025-08-19",{"date":97,"type":38},"2025-08-24",{"date":95,"type":38},{"date":100,"type":21},"2027-04",{"name":102,"class":74},"Chimivac INC"]