Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein

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
120 (estimated)
Sponsor
Hangzhou Gensciences Biopharmaceutical Co., Ltd. · Industry
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About This Trial
To evaluate the prophylactic efficacy of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. To evaluate the safety of recombinant human coagulation factor Ⅷ-Fc fusion protein (FRSW117) for injection in patients with severe hemophilia A. Secondary purpose: To evaluate the efficacy of recombinant human coagulation factor Ⅷ-Fc fus…
Trial Locations
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Eligibility Criteria
inclusion Criteria: * 12≤ age ≤65 year-old men; * Patients with clinically confirmed severe hemophilia A, i.e. at screening (central laboratory testing) or previous medical records confirm: FⅧ activity \< 1%; * Previous documented treatment with any recombinant and/or blood-derived coagulation fact…
Contacts

Chen Ling

+ 86 15896762713

chenling@gensciences.cn

CONTACT

Renchi Yang, PhD

CONTACT