๐ŸŒ EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)

RecruitingPhase 1, Phase 2Ages 18 Years - anyMaleBiocad
NCT06120582 on ClinicalTrials.gov โ†—
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 ะ’. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male with hemophilia B. 2. Age โ‰ฅ18 years. 3. FIX activity at screening โ‰ค2% without FIX inhibitor. 4. โ‰ฅ150 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.
๐Ÿ’Š

What it tests

  • ANB-002, dose 1
  • ANB-002, dose 2
  • ANB-002, dose 3
๐Ÿ“

Where

17 sites
Republican Scientific and Practical Center for Radiation Medicine and Human Ecology
Homyel, Belarus
Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
Minsk, Belarus
State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Russia
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina, Russia
Kuzbass Clinical Hospital named after S.V. Belyaev
Kemerovo, Russia
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, Russia
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
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

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy