[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai RAAS Blood Products Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100647597","phase-2-a-phase-ii-exploratory-study-of-sr604-injection-evaluating-the-safety-and-efficacy-in-the-treatment-of-congenital-coagulation-factor-vii-deficiency-100647597",false,"NCT07711158","A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII Deficiency","An Open-Label, Multicenter, Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of SR604 Injection in Patients With Congenital Coagulation Factor VII Deficiency","Inclusion Criteria:\n\n1. Age ≥12 years and ≤65 years at the time of signing the informed consent form; both genders eligible;\n2. Clinically diagnosed with congenital coagulation Factor VII deficiency, with historical or screening FVII activity \\\u003C10%, and ≥2 treated new-onset bleeding events within 3 months prior to enrollment;\n3. No active bleeding symptoms prior to first administration of SR604 Injection;\n4. The subject and\u002For legal representative and impartial witness have signed the informed consent form, indicating voluntary agreement to participate in this trial, to provide biological samples for testing as required by the protocol, and to comply with the planned study visits;\n5. Female subjects (post-menarche) must have a negative serum pregnancy test (HCG) during the screening period; subjects with childbearing potential (females post-menarche or males post-spermarche) must agree to use highly effective contraceptive measures throughout the study period.\n\nExclusion Criteria:\n\n1. Known history of hypersensitivity to the study drug formulation or any of its components;\n2. Intolerance to subcutaneous injection or other local skin abnormalities or dermatoses that may affect drug administration or safety assessment;\n3. Meeting any one of the following criteria during screening:\n\n   1. Hemoglobin \\\u003C60 g\u002FL;\n   2. Platelet count \\\u003C100×10⁹\u002FL;\n   3. Abnormal hepatic or renal function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5× upper limit of normal (ULN), or total bilirubin ≥1.5× ULN; or serum creatinine (Cr) ≥1.5× ULN;\n   4. Positive for anti-human immunodeficiency virus (HIV) antibodies.\n4. Any bleeding disorder other than congenital Factor VII deficiency, or other conditions causing significantly abnormal coagulation parameters (e.g., hemophilia A or B, von Willebrand disease, platelet disorders, vitamin K deficiency, etc.);\n5. Protein C deficiency or Protein S deficiency;\n6. History of thrombosis, family history of thrombosis, or history of thrombophilia;\n7. Intracranial hemorrhage within 2 years prior to signing the informed consent form;\n8. Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association class ≥III), serious arrhythmia (QTc interval \\>450 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), etc.;\n9. Female patients with menstrual abnormalities caused by organic gynecological conditions (e.g., uterine fibroids, endometriosis, adenomyosis, etc.);\n10. Received Factor VII-containing products within 48 hours prior to first administration of SR604 Injection; received whole blood or plasma transfusion within 2 weeks prior to first administration of SR604 Injection;\n11. Used any anticoagulants, antifibrinolytics, or agents affecting platelet function (including chemical drugs, biological products, or traditional Chinese medicine), including aspirin, within 1 week prior to screening, or required use of such agents during the treatment period;\n12. Underwent major surgery (defined as Grade III or IV surgery) within 1 month prior to signing the informed consent form, or planned to undergo surgery during the study period;\n13. Enrolled in other clinical trials within 1 month prior to signing the informed consent form;\n14. Miscarriage or pregnancy termination within 3 months prior to signing the informed consent form; pregnant or breastfeeding women;\n15. Mental illness or significant psychiatric disorder, or incapacity or lack of cognitive ability due to other causes;\n16. Other conditions deemed by the investigator to be unsuitable for enrollment, such as alcoholism, anticipated poor subject compliance preventing completion of dosing and study follow-up, poorly controlled comorbid chronic diseases, or serious systemic diseases.\n\n    \\-","ALL","18 Years","65 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter, exploratory Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of SR604 Injection in patients with congenital coagulation Factor VII deficiency.",[27],"Factor VII Deficiency","NOT_YET_RECRUITING","2026-07-14",{"date":31,"type":32},"2026-07-17","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Shanghai RAAS Blood Products Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100641949","phase-1-an-open-label-multicenter-phase-iii-clinical-trial-to-evaluate-the-safety-tolerability-efficacy-and-pharmacokineticpharmacodynamic-pkpd-characteristics-of-sr604-injection-in-patients-with-hemophilia-ab-and-congenital-factor-vii-deficiency-100641949","NCT07644832","An Open-label, Multicenter Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic\u002FPharmacodynamic (PK\u002FPD) Characteristics of SR604 Injection in Patients With Hemophilia A\u002FB and Congenital Factor VII Deficiency","Inclusion Criteria:\n\n1. Age ≥18 years and ≤65 years at the time of signing informed consent, regardless of sex;\n2. Clinically diagnosed with Hemophilia A or B or congenital coagulation Factor VII deficiency, and must meet the following criteria:\n\n   1. Hemophilia A or B patients with historical or screening FVIII activity level \\\u003C1% or FIX activity level ≤2%; Note: Hemophilia A or B patients with or without inhibitors may be enrolled. For patients without inhibitors (inhibitor titer \\\u003C0.6 BU\u002FmL), they must have previously received coagulation factor treatment with exposure days (EDs) \\>50 days.\n   2. Congenital coagulation Factor VII deficiency patients with historical or screening FVII activity \\\u003C10%;\n3. Part A only: Received on-demand treatment with FVIII, FIX, recombinant human coagulation Factor VIIa (rFVIIa), or PCC for bleeding events within 1 month prior to screening;\n4. Part B\u002FPart C only: Accessible bleeding and treatment records (factor replacement or bypassing agent therapy) for at least 3 months prior to enrollment. Hemophilia A or B patients must have received on-demand treatment with ≥3 treated de novo bleeding episodes within 3 months prior to enrollment. Congenital coagulation Factor VII deficiency patients must have ≥2 treated de novo bleeding episodes within 3 months prior to enrollment;\n5. No active bleeding symptoms prior to first dosing;\n6. The subject or a legally acceptable representative has a full understanding of and can comply with the protocol requirements, has the willingness to complete the study as planned, and voluntarily agrees to provide biological samples for testing as required by the protocol;\n7. The subject is able to understand the procedures and methods of this clinical trial, has been fully informed, and voluntarily participates in the trial by personally signing the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with a known history of hypersensitivity to the investigational medicinal product or any of its components;\n2. Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect administration and safety assessment;\n3. Subjects meeting any of the following criteria at screening:\n\n   1. Hemoglobin \\\u003C60 g\u002FL;\n   2. Platelet count \\\u003C100 × 10\\^9\u002FL;\n   3. Hepatic or renal impairment: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5 × upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN; or serum creatinine (Cr) ≥1.5 × ULN;\n4. Positive result(s) for hepatitis B virus surface antigen (HBsAg), anti-human immunodeficiency virus (HIV) antibody, and\u002For Treponema pallidum-specific antibody;\n5. Clinically diagnosed with active hepatitis C;\n6. Any other bleeding disorder or any other disease causing significant coagulation abnormalities (e.g., platelet disorders, vitamin K deficiency, etc.) other than Hemophilia A or B and congenital coagulation Factor VII deficiency;\n7. Protein C deficiency or protein S deficiency;\n8. History of or current thrombosis, family history of thrombosis, or history of thrombophilia prior to signing informed consent;\n9. Intracranial hemorrhage due to Hemophilia A or B or congenital coagulation Factor VII deficiency within 2 years prior to screening;\n10. Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association Class ≥III), severe arrhythmia (QTc interval \\>450 ms, corrected by Fridericia's formula), or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg);\n11. Received recombinant human coagulation Factor VIIa (rFVIIa) within 48 hours prior to first dosing; received any FVIII-containing product within 72 hours prior to first dosing; received any FIX-containing product within 96 hours prior to first dosing; long-acting products of the above have not completed a washout of 5 half-lives;\n12. Used or requires use of any anticoagulant, antifibrinolytic agent, or chemical drug, biological product, or traditional Chinese medicine affecting platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, within 1 week prior to first dosing or during the trial;\n13. Received whole blood or plasma therapy within 2 weeks prior to first dosing;\n14. Received emicizumab treatment within 6 months prior to first dosing;\n15. Received or planned to receive vaccination within 4 weeks prior to first dosing or during the trial;\n16. Underwent major surgery (e.g., orthopedic surgery, abdominal surgery) within 1 month prior to first dosing, or planned to undergo surgery during the study;\n17. Enrolled in another clinical trial within 1 month prior to first dosing;\n18. History of drug abuse or alcoholism (alcoholism criteria: long-term drinking history exceeding 5 years, equivalent to ethanol intake ≥40 g\u002Fday, or heavy drinking within 2 weeks, equivalent to ethanol intake \\>80 g\u002Fday. Ethanol amount (g) conversion formula = alcohol volume (mL) × ethanol content (%) × 0.8);\n19. Psychiatric illness or significant mental impairment, or incapacity or lack of cognitive ability due to other reasons;\n20. Plans to have children or donate sperm during the entire trial period up to 6 months after the last dose, or unwilling to use effective physical contraceptive measures (e.g., condoms);\n21. Subjects with clinically significant disease or other conditions that the investigator considers unsuitable for participation in the clinical trial (e.g., the patient cannot benefit from the clinical trial);\n22. Subjects deemed by the investigator to have poor compliance, rendering efficacy evaluation impossible or with low likelihood of completing the planned treatment course and follow-up.",{"count":48,"type":21},76,[50,24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, immunogenicity , PK, and PD of a single dose of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors （Part A）and to evaluate the safety, PK, PD, and efficacy of multiple doses of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B and Part C).",[53,54,27],"Hemophilia A","Hemophilia B","RECRUITING","2026-06-08",{"date":58,"type":32},"2026-06-12",{"date":60,"type":32},"2024-05-31",{"date":62,"type":21},"2026-12-31",{"name":38,"class":39},9,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":64},"100643086","phase-2-a-phase-ii-clinical-trial-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-sr604-injection-in-patients-with-von-willebrand-disease-100643086","NCT07640893","A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease","A Multi-Dose, Randomized, Multicenter Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of SR604 Injection in Patients With Von Willebrand Disease","Inclusion Criteria:\n\n* Patients must meet ALL of the following inclusion criteria to be enrolled:\n\n  1. Age \\>= 18 years and \\\u003C= 65 years at the time of signing informed consent, regardless of sex;\n  2. At screening, patients with a confirmed diagnosis of von Willebrand disease (VWD) with documented evidence and a defined VWD subtype;\n  3. At least 4 new bleeding episodes within 6 months prior to screening;\n  4. No active bleeding symptoms prior to the first dose;\n  5. The subject or impartial witness fully understands and is able to comply with the protocol requirements, is willing to complete the study as planned, and voluntarily agrees to provide biological samples for testing as required by the protocol; is able to understand the procedures and methods of this clinical trial, provides voluntary participation after full informed consent, and personally signs the informed consent form.\n\nExclusion Criteria:\n\n* Patients meeting ANY of the following exclusion criteria will not be enrolled:\n\n  1. Known history of hypersensitivity to the investigational drug formulation or any of its components;\n  2. Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect drug administration and safety assessment;\n  3. Meeting any of the following criteria at screening:\n\n     1. Hemoglobin \\\u003C 60 g\u002FL;\n     2. Platelet count \\\u003C 80 x 10\\^9\u002FL;\n     3. Hepatic or renal dysfunction: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>= 2.5 x upper limit of normal (ULN), or total bilirubin \\>= 1.5 x ULN; or serum creatinine (Cr) \\>= 1.5 x ULN;\n  4. Positive for anti-human immunodeficiency virus (HIV) antibody;\n  5. Presence of any bleeding disorder other than von Willebrand disease \\[hemophilia A or B, congenital coagulation factor VII deficiency, acquired von Willebrand disease (AVWS), platelet-type VWD, inherited platelet disorders, etc.\\]; or significantly abnormal coagulation parameters due to diseases other than von Willebrand disease (e.g., platelet disorders, vitamin K deficiency, etc.);\n  6. Presence of protein C deficiency or protein S deficiency;\n  7. History of thrombosis or family history of thrombosis prior to signing informed consent or currently, or history of thrombophilia;\n  8. Severe bleeding due to VWD within 2 years prior to screening, such as intracranial hemorrhage, esophageal variceal bleeding, etc.;\n  9. Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association class \\>= III), severe arrhythmia (QTc interval \\> 500 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic blood pressure \\>= 160 mmHg or diastolic blood pressure \\>= 100 mmHg), etc.;\n  10. Female patients with menstrual abnormalities due to organic gynecological diseases (e.g., uterine fibroids, endometriosis, adenomyosis, etc.);\n  11. Previous or current life-threatening malignant neoplasms or end-stage liver disease;\n  12. Use of DDAVP or plasma-derived VWF-containing factor VIII concentrate, plasma-derived\u002Frecombinant VWF preparations, or antifibrinolytic therapy within 1 week prior to the first dose;\n  13. Use of antithrombotic agents within 1 week prior to the first dose;\n  14. Receipt of fresh blood\u002Fplasma or cryoprecipitate therapy within 2 weeks prior to the first dose;\n  15. Receipt of vaccination within 1 month prior to the first dose or planned vaccination during the study period;\n  16. Major surgery (major surgery defined as Grade III and IV surgeries) within 1 month prior to the first dose, or planned surgery during the study period;\n  17. Enrollment in other clinical trials within 1 month prior to the first dose;\n  18. History of drug abuse or alcohol dependence (alcohol dependence criteria: long-term drinking history exceeding 5 years, equivalent ethanol intake \\>= 40 g\u002Fday, or heavy drinking within 2 weeks, equivalent ethanol intake \\> 80 g\u002Fday. Ethanol amount (g) conversion formula = alcohol consumption (mL) x alcohol content (%) x 0.8);\n  19. Presence of psychiatric disease or significant mental disorder, or other reasons resulting in incapacity or lack of cognitive ability;\n  20. Plans for procreation or sperm donation throughout the study period up to 3 months after the last dose, or unwillingness to use effective physical contraceptive measures (e.g., condoms);\n  21. Presence of clinically significant disease or other reasons rendering the patient unsuitable for clinical trial participation in the investigator's opinion (e.g., patient unlikely to benefit from the clinical trial);\n  22. Patients whom the investigator considers to have poor compliance, rendering efficacy evaluation difficult or likelihood of completing the planned treatment course and follow-up low.",{"count":73,"type":21},24,[24],"The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.",[77],"Von Willebrand Disease (VWD)","2026-06-05",{"date":80,"type":32},"2026-06-11",{"date":82,"type":32},"2025-11-26",{"date":84,"type":21},"2027-12-31",{"name":38,"class":39},""]