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-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels. BBM-H901 is an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene and raises circulating levels of endogenous FIX.
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Single dose intravenous injection of BBM-H901GENETIC
Single dose intravenous infusion of BBM-H901, an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene in liver.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| Nanfang Hospital Southern Medical University | Guangzhou | Guangdong | China |
| The Second People's Hospital of Shenzhen | Shenzhen | Guangdong | China |
| North China University of Science and Technology Affiliated Hospital | Tangshan | Hebei | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| The Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 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 |