Clinical Trial

Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs

Recruiting Phase 2/3
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Summary
This is a multi-center, Phase 1/2/3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects. BBM-H803 is an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene and raises circulating levels of endogenous FVIII.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-31; most recent amendment 2026-03-13.
Trial Details
NCT Number NCT06111638
Lead Sponsor Shanghai Xinzhi BioMed Co., Ltd.
Collaborators: Shanghai Mianyi Biopharmaceutical Co., Ltd.
Conditions Hemophilia A
Enrollment 55 participants
Start Date 2024-01-03
Primary Completion 2027-05-30 (estimated)
Study Completion 2031-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-17