Status:
COMPLETED
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
Lead Sponsor:
Zhengzhou Gensciences Inc
Collaborating Sponsors:
Jiangsu Gensciences lnc.
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04845399
Start Date
April 16 2021
End Date
June 26 2021
Last Update
August 29 2023
Active Locations (16)
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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
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000