Tests ANB-002 gene therapy in adults with hemophilia B
Tests the ANB-002 gene therapy in adults with hemophilia B.
Plain-language title generated from the registry record
Registry title: Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
Key facts
- Where
- Homyel and Minsk, BelarusSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult men with hemophilia B who have low factor IX (FIX) activity and long previous treatment with FIX concentrates. It tests the safety and effect of ANB-002.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Hemophilia B with FIX activity at screening of 2% or less, without FIX inhibitor
- Earlier treatment
- At least 150 previous exposure days of treatment with FIX concentrates. No previous gene therapy.
- Biomarker or test result
- FIX activity at screening 2% or less, no FIX inhibitor. No positive Anti-AAV5 antibodies (for Cohorts 1-3).
Main reasons for not taking part
- Previous gene therapy
- Other blood or hematopoietic disorders
- Positive Anti-AAV5 antibodies (for Cohorts 1-3)
- HIV infection not controlled with anti-viral therapy
- Hepatitis B (for Cohorts 1-3) or acute or chronic hepatitis C
Read by machine on 12 November 2026.
Where in Belarus
- Republican Scientific and Practical Center for Radiation Medicine and Human EcologyHomyel, BelarusContact: Dmitrii NovikTaking people
- Minsk Scientific and Practical Center for Surgery, Transplantology and HematologyMinsk, BelarusContact: Anatoly UssTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Biocad
- Trial code
- NCT06120582
- Record updated
- 13 June 2025
- Original description
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.Read full original descriptionShow less
An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B
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.
Inclusion: Male with hemophilia B; Age ≥18 years; FIX activity at screening ≤2% without FIX inhibitor; ≥150 previous exposure days of treatment with FIX concentrates.
Exclusion: Previous gene therapy; Positive Anti-AAV5 antibodies (for Cohorts 1-3); 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); Malignancies with remission <5 years.