Actively Recruiting
Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
Led by Biocad · Updated on 2025-06-13
28
Participants Needed
17
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia В. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.
CONDITIONS
Official Title
Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male with hemophilia B.
- Age 18 years or older.
- Factor IX activity at screening 2% or less without factor IX inhibitor.
- At least 150 previous exposure days to treatment with factor IX concentrates.
You will not qualify if you...
- Previous gene therapy.
- Other blood or hematopoietic disorders.
- Positive Anti-AAV5 antibodies (for Cohorts 1-3).
- Diagnosed HIV infection not controlled with antiviral therapy.
- Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.
- Any active systemic infections or recurrent infections needing systemic therapy at screening.
- Any other disorders causing severe immunodeficiency.
- Significant liver disorders such as cirrhosis or fibrosis.
- Malignancies with remission less than 5 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Republican Scientific and Practical Center for Radiation Medicine and Human Ecology
Homyel, Belarus, 246040
Actively Recruiting
2
Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
Minsk, Belarus, 220089
Actively Recruiting
3
State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Russia, 454048
Actively Recruiting
4
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina, Russia, 188300
Actively Recruiting
5
Kuzbass Clinical Hospital named after S.V. Belyaev
Kemerovo, Russia, 650066
Actively Recruiting
6
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, Russia, 610027
Actively Recruiting
7
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
8
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
9
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, Russia, 125284
Actively Recruiting
10
LLC "Medis"
Nizhny Novgorod, Russia, 603137
Actively Recruiting
11
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russia, 630087
Actively Recruiting
12
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, Russia, 191024
Actively Recruiting
13
City Polyclinic №37
Saint Petersburg, Russia, 191186
Actively Recruiting
14
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341
Actively Recruiting
15
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
16
State Institution "Komi Republican Oncological Dispensary"
Syktyvkar, Russia, 167904
Actively Recruiting
17
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
Research Team
A
Anna Eremeeva, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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