Health Trials

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

ConditionHemophilia B
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorBiocad

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ANB-002

Treatment groups

24 Participants
are divided into 2 treatment groups

Locations

14
Russia
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"610027, Kirov Russia
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"125284, Moscow 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)125167, Moscow Russia

Sponsors and collaborators

Biocad

Lead sponsor

Source ClinicalTrials.gov