Evaluation of the Safety and Efficacy of Hemophilia A Gene Therapy Drugs
Recruiting now · Phase 2/Phase 3
Conditions studied: Hemophilia A
In brief
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.
Key facts
- Study ID
- NCT06111638
- Run by
- Shanghai Xinzhi BioMed Co., Ltd.
- People needed
- 55
- Starts
- 2024-01-03
- Expected to finish
- 2031-05-30
- Last updated by the study team
- 2026-03-17
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Southern Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
- Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (enrolling)
- Wuhan Union Hospital Affiliated to Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
- Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
- The Affiliated Hospital of Northwest University Xi'an No.3 Hospital — Xi’an, Shanxi, China (enrolling)
- Sichuan Provincial People's Hospital — Chengde, Sichuan, China (enrolling)
- Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China (enrolling)
- The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
Full record on ClinicalTrials.gov
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