Status:
COMPLETED
An Open Label Study to Determine the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A.
Lead Sponsor:
Zhengzhou Gensciences Inc
Conditions:
Hemophilia A
Eligibility:
MALE
12-60 years
Phase:
PHASE3
Brief Summary
The primary objectives of the study are to evaluate the efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in the Prevention and Treatment of Bleeding in p...
Eligibility Criteria
Inclusion
- 1)Male, aged 12 to 60 years
- 2)Severe hemophilia A. The activity of the coagulation factor VIII (FVIII:C) \< 1%, and previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
- 3\) No history of a positive inhibitor test (\< 0.6 BU) or clinical signs of decreased response to FVIII administrations within 2 years before the test or during the screening period. No Family history of inhibitors.
- 4\) Non-immune deficiency, with a certain immune capacity (CD4 \> 200/μL)
- 5\) Platelet count \> 100,000 platelets/μL.
- 6\) Normal prothrombin time or INR \< 1.3.
- 7\) Normal previous results of vWF antigen examination.
- 8\) Negative lupus anticoagulant.
- 9\) the patient has a detailed record of bleeding events for at least 6 months (the subject can be admitted to the on-demand treatment group with spontaneous bleeding ≥3 times within 6 months).
- 10\) Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).
Exclusion
- 1\) Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
- 2\) History of hypersensitivity or anaphylaxis associated with any FVIII or II immunoglobulin administration.
- 3\) Other coagulation disorder(s) in addition to hemophilia A.
- 4\) Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level).
- 5\) Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
- 6\) Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 3 × upper limit of normal (ULN), BUN \> 2×ULN, Cr \> 176.8µmol/L).
- 7\) Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
- 8\) Patients having major surgery or receiving blood or blood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
- 9\) Patients who previously participated in the other clinical trials within 1 month prior screening.
- 10\) One or more clinically significant tests for Hepatitis B Virus Surface Antigen, Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
- 11\) Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
- 12\) Patient who is considered by the other investigators not suitable for clinical study.
- NOTE:Other protocol-defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04456387
Start Date
October 15 2020
End Date
September 30 2021
Last Update
December 13 2023
Active Locations (17)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Capital Medical University affiliated Beijing Children's Hospital
Beijing, Beijing Municipality, China, 100045
3
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China, 404000
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001