Study of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein (FRSW107) On-Demand Treatment

Recruiting Phase 3 Interventional Study
Severe Hemophilia A
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 65
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Hangzhou Gensciences Biopharmaceutical Co., Ltd. · Industry
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About This Trial
The indication for this product is to control bleeding in patients with hemophilia A (congenital deficiency of factor VIII). The primary objective: Evaluation of the efficacy of recombinant human coagulation factor VIII-Fc fusion protein for injection (FRSW107) as an on-demand treatment in previously treated patients with severe hemophilia A. Secondary objectives: Evaluation of the safety and …
Trial Locations
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Eligibility Criteria
Inclusive Criteria: 1. Males aged 12 or younger to 65 years old. 2. Patients clinically diagnosed with severe hemophilia A, i.e., those confirmed through screening or previous medical records: FⅧ Activity \< 1%. 3. Previous records confirm receipt of any recombinant and/or blood-derived coagulation…
Contacts

Lijia Liu

+ 86 1645377793

lijialiu@gensciences.cn

CONTACT