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 (RH-107-III02)

Zhengzhou Gensciences

Status and phase: Completed; Phase 3

Conditions: Hemophilia A

Treatments: Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04845399

CTR20210593

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Male

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Arm 1

Experimental group

Description:

Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.

Treatment:

Drug: Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection