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.
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