Actively Recruiting
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Led by Biocad · Updated on 2025-11-18
24
Participants Needed
14
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men diagnosed with hemophilia B aged 18 or older
- FIX activity 2%
- Absence of FIX inhibitor
- At least 150 previous exposure days of treatment with FIX concentrates
You will not qualify if you...
- Any blood or hematopoietic organ diseases other than hemophilia B
- History of any gene therapy, including ANB-002
- Diagnosed HIV infection not controlled with antiviral therapy
- Active hepatitis B or C infection
- Presence of anti-AAV5 antibodies
- Any active or recurrent infections requiring systemic therapy
- Disorders associated with severe immunodeficiency
- Significant liver disorders or symptoms indicating liver disease
- Malignancies with less than 5 years of remission
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 14 locations
1
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, Russia
Actively Recruiting
2
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, Russia, 610027
Actively Recruiting
3
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, 125167
Actively Recruiting
4
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, 125167
Actively Recruiting
5
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, Russia, 125284
Actively Recruiting
6
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russia, 630087
Actively Recruiting
7
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, Russia, 188663
Actively Recruiting
8
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, Russia, 193024
Actively Recruiting
9
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341
Actively Recruiting
10
Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation
Samara, Russia, 443099
Actively Recruiting
11
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation
Ufa, Russia, 450008
Actively Recruiting
12
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Not Yet Recruiting
13
Ramathibodi Hospital
Bangkok, Thailand, 10400
Not Yet Recruiting
14
Siriraj Hospital
Bangkok, Thailand, 10700
Not Yet Recruiting
Research Team
A
Anna Eremeeva, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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