An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

Recruiting now · Phase 3

Conditions studied: Hemophilia B

In brief

The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.

Key facts

Study ID

NCT06700096

Run by

Biocad

People needed

24

Starts

2024-11-07

Expected to finish

2032-03-01

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men diagnosed with hemophilia B aged 18 or older
• FIX activity ≤2%
• Absense of FIX inhibitor
• ≥150 previous exposure days of treatment with FIX concentrates

You may not qualify if…

• Any diseases of blood and hematopoietic organs other than hemophilia B
• A history of any gene therapy, including ANB-002
• Diagnosed HIV-infection, not controlled with anti-viral therapy
• Active HBV or HCV infection
• Anti-AAV5 antibodies
• Any active systemic infections or recurrent infections requiring systemic therapy
• Any other disorders associated with severe immunodeficiency
• Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder
• Malignancies with less than 5 years of remission

Where it is running

• Chelyabinsk Regional Clinical Hospital — Chelyabinsk, Russia (enrolling)
• Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency" — Kirov, Russia (enrolling)
• 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 (enrolling)
• 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 (enrolling)
• Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin" — Moscow, Russia (enrolling)
• State Novosibirsk Regional Clinical Hospital — Novosibirsk, Russia (enrolling)
• State budgetary healthcare institution Leningrad Regional Clinical Hospital — Saint Petersburg, Russia (enrolling)
• Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency — Saint Petersburg, Russia (enrolling)
• Almazov National Medical Research Centre — Saint Petersburg, Russia (enrolling)
• Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation — Samara, Russia (enrolling)
• Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation — Ufa, Russia (enrolling)
• King Chulalongkorn Memorial Hospital — Bangkok, Thailand
• Ramathibodi Hospital — Bangkok, Thailand
• Siriraj Hospital — Bangkok, Thailand

Full record on ClinicalTrials.gov

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