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A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Viral Vector Containing an Expression Cassette of the Human Factor VIII Transgene (BBM-H803) Injection in Participants With Hemophilia A

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects voluntarily sign informed consent form;

• Males ≥ 18 years;

• Subjects are clinically diagnosed with severe hemophilia A;

• Have \> = 150 documented exposure days to a Factor VIII protein product

• No prior history of hypersensitivity or anaphylaxis associated with any FVIII immunoglobulin;

• Use a reliable contraception method during the study;

• Capsid antibody negative;

• Subjects have good compliance.

Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Xiangya Hospital Central South University
RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengde
Southern Hospital, Southern Medical University
RECRUITING
Guangzhou
Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Wuhan Union Hospital Affiliated to Huazhong University of Science and Technology
RECRUITING
Wuhan
The Affiliated Hospital of Northwest University Xi'an No.3 Hospital
RECRUITING
Xi’an
Contact Information
Primary
Wenqi Shao, Master
ra@beliefbiomed.com
13636317441
Time Frame
Start Date: 2024-01-03
Estimated Completion Date: 2031-05-30
Participants
Target number of participants: 55
Treatments
Experimental: Arm of BBM-H803
1×10\^13 vg/kg, Single-dose treatment
Related Therapeutic Areas
Blood Clots
Hemophilia A
Sponsors
Leads: Shanghai Xinzhi BioMed Co., Ltd.
Collaborators: Shanghai Mianyi Biopharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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