Study 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.
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Single dose intravenous injection of BBM-H803GENETIC
Single dose intravenous infusion of BBM-H803, an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene in liver. The dose of BBM-H803 will be calculated according to participant's weight.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
| Southern Hospital, Southern Medical University | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| Wuhan Union Hospital Affiliated to Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| The Affiliated Hospital of Northwest University Xi'an No.3 Hospital | Xi’an | Shanxi | China |
| Sichuan Provincial People's Hospital | Chengde | Sichuan | China |
| Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | Tianjin Municipality | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |