NCT06120582RecruitingPhase 1/2
Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 2 May 2023
- Primary completion date
- Nov 2025
- Lead sponsor
- Biocad
- Diseases
- Haemophilia
- NCT number
- NCT06120582
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 28
- From 2 May 2023 to the primary completion date, Nov 2025
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gene therapy.
- Positive Anti-AAV5 antibodies (for Cohorts 1-3).
Other illness
- Other blood or hematopoietic disorders.
- Diagnosed HIV-infection, not controlled with anti-viral therapy.
- Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.
- Any active systemic infections or recurrent infections requiring systemic therapy at screening.
- Any other disorders associated with severe immunodeficiency.
- Significant hepatic disorders (liver cirrhosis, liver fibrosis, etc).
Age
- Malignancies with remission \<5 years.
Who the study is looking for
- Male with hemophilia B.
- Age ≥18 years.
- FIX activity at screening ≤2% without FIX inhibitor.
- ≥150 previous exposure days of treatment with FIX concentrates.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Republican Scientific and Practical Center for Radiation Medicine and Human Ecology Coordinator of this site? Confirm its status | Homyel | Belarus | Recruiting |
| Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology Coordinator of this site? Confirm its status | Minsk | Belarus | Recruiting |
| State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital" Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Recruiting |
| State budgetary healthcare institution Leningrad Regional Clinical Hospital Coordinator of this site? Confirm its status | Gatchina | Russia | Recruiting |
| Kuzbass Clinical Hospital named after S.V. Belyaev Coordinator of this site? Confirm its status | Kemerovo | Russia | Recruiting |
| Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency" Coordinator of this site? Confirm its status | Kirov | Russia | Recruiting |
| Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin" Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| 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) Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| 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) Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| LLC "Medis" Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Recruiting |
| State Novosibirsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
| City Polyclinic №37 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Almazov National Medical Research Centre Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation Coordinator of this site? Confirm its status | Samara | Russia | Recruiting |
| State Institution "Komi Republican Oncological Dispensary" Coordinator of this site? Confirm its status | Syktyvkar | Russia | Recruiting |
| Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation Coordinator of this site? Confirm its status | Ufa | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.