NCT06120582 Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
| NCT ID | NCT06120582 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Biocad |
| Condition | Hemophilia B |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2023-05-02 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male with hemophilia B. 2. Age ≥18 years. 3. FIX activity at screening ≤2% without FIX inhibitor. 4. ≥150 previous exposure days of treatment with FIX concentrates. Exclusion Criteria: 1. Previous gene therapy. 2. Other blood or hematopoietic disorders. 3. Positive Anti-AAV5 antibodies (for Cohorts 1-3). 4. Diagnosed HIV-infection, not controlled with anti-viral therapy. 5. Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C. 6. Any active systemic infections or recurrent infections requiring systemic therapy at screening. 7. Any other disorders associated with severe immunodeficiency. 8. Significant hepatic disorders (liver cirrhosis, liver fibrosis, etc). 9. Malignancies with remission \<5 years.
Contact & Investigator
Arina V Zinkina-Orikhan, MD
STUDY DIRECTOR
Director of Clinical Development Department, BIOCAD
Frequently Asked Questions
Who can join the NCT06120582 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Hemophilia B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06120582 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06120582 currently recruiting?
Yes, NCT06120582 is actively recruiting participants. Contact the research team at eremeevaav@biocad.ru for enrollment information.
Where is the NCT06120582 trial being conducted?
This trial is being conducted at Homyel, Belarus, Minsk, Belarus, Chelyabinsk, Russia, Gatchina, Russia and 11 additional locations.
Who is sponsoring the NCT06120582 clinical trial?
NCT06120582 is sponsored by Biocad. The principal investigator is Arina V Zinkina-Orikhan, MD at Director of Clinical Development Department, BIOCAD. The trial plans to enroll 28 participants.