Brief Title
Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
Official Title
A Single-Arm, Multicenter, Open-label Phase III Expansion Trial Evaluating Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A
Brief Summary
The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Annualized Bleeding Rates (ABR).
Secondary Outcome
Total Dose Required for Resolution of a Bleeding Episode.
Condition
Hemophilia A
Intervention
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Study Arms / Comparison Groups
Arm 1
Description: Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
April 16, 2021
Completion Date
December 30, 2022
Primary Completion Date
July 30, 2022
Eligibility Criteria
Inclusion Criteria: - Patients Who have Completed trial of RH-107-001 (previously treated patients) Previously received Recombinant Human Coagulation Factor VIII-Fc prophylactic. - The patient and/or guardian or his or her legal representative must be able to read, understand, and provide signed informed consent, And voluntarily signed the Informed Consent Form. - The compliance of patients appeared quite well. - Patient who is considered by the investigators suitable for ongoing to accept previously treated. Exclusion Criteria: - Subjects who have not completed trial of RH-107-001or who have completed the Phase III clinical trial but not willing to continue receiving treatment. - Subjects who did not participate in the Phase III clinical trial of RH-107-001.
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Renchi Yang, +86-010-67806990, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04845399
Organization ID
CTR20210593
Responsible Party
Sponsor
Study Sponsor
Zhengzhou Gensciences Inc
Collaborators
Jiangsu Gensciences lnc.
Study Sponsor
Renchi Yang, Principal Investigator, Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Verification Date
April 2021