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

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhengzhou Gensciences Inc
• Collaborators: Jiangsu Gensciences lnc; Jiangsu Gensciences lnc.
• Treatments: Factor VIII

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.