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

RecruitingPhase 3Ages 18 Years - anyMaleBiocad
NCT06700096 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • ANB-002
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Where

14 sites
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 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
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, Russia
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, Russia

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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