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An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Sponsor: Biocad
Summary
The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-11-07
Completion Date
2032-03
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
ANB-002
Adeno-associated viral vector carrying the FIX gene single infusion
Locations (14)
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, Russia
Federal State Budgetary Institution "National Medical Research Centre for Hematology" of the Ministry of Health of Russian Federation (Department of Clinical Diagnostics for Hematology and Hemostasis Disorders)
Moscow, Russia
Federal State Budgetary Institution "National Medical Research Centre for Hematology" of the Ministry of Health of Russian Federation (Department of Traumatology and Reconstructive and Restorative Orthopedics for Patients with Hemophilia)
Moscow, Russia
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russia
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, Russia
Almazov National Medical Research Centre
Saint Petersburg, Russia
Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation
Samara, Russia
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation
Ufa, Russia
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand