An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Men diagnosed with hemophilia B aged 18 or older
• FIX activity ≤2%
• Absense of FIX inhibitor
• ≥150 previous exposure days of treatment with FIX concentrates
Locations
Other Locations
Russian Federation
Chelyabinsk Regional Clinical Hospital
RECRUITING
Chelyabinsk
Federal State Budgetary Organization of Science Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency
RECRUITING
Kirov
Federal Budgetary Institution Moscow City Clinical Hospital named after S. P. Botkin
RECRUITING
Moscow
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)
RECRUITING
Moscow
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)
RECRUITING
Moscow
State Novosibirsk Regional Clinical Hospital
RECRUITING
Novosibirsk
Almazov National Medical Research Centre
RECRUITING
Saint Petersburg
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
RECRUITING
Saint Petersburg
State budgetary healthcare institution Leningrad Regional Clinical Hospital
RECRUITING
Saint Petersburg
Federal State Budgetary Educational Institution of Higher Education Samara State Medical University of the Ministry of Healthcare of the Russian Federation
RECRUITING
Samara
Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry of Healthcare of the Russian Federation
RECRUITING
Ufa
Contact Information
Primary
Anna Eremeeva, MD PhD
eremeevaav@biocad.ru
+7 (812) 380 49 34
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2032-03
Participants
Target number of participants: 24
Treatments
No_intervention: Lead-in
All subjects will be enrolled in the Lead-in period in order to collect information on individual bleeding rate anf FIX concentrates consumption
Experimental: ANB-002 (arvenacogene sanparvovec)
After completion of lead-in period subjects will enter the main period which starts with ANB-002 (arvenacogene sanparvovec) infusion.
Related Therapeutic Areas
Sponsors
Leads: Biocad