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RecruitingPhase 3NCT06700096

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

Sponsor

Biocad

Enrollment

24 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Hemophilia B

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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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Interventions

GENETICANB-002

Adeno-associated viral vector carrying the FIX gene single infusion

Locations(14)

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

Almazov National Medical Research Centre

Saint Petersburg, Russia

Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation

Samara, Russia

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation

Ufa, Russia

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Ramathibodi Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

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NCT06700096

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