RecruitingPhase 1Phase 2NCT06120582

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

An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B

Sponsor

Biocad

Enrollment

28 participants

Start Date

May 2, 2023

Study Type

INTERVENTIONAL

Conditions

Hemophilia B

Summary

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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ANB-002, dose 1, ANB-002, dose 2, and others for people with hemophilia b. The study is currently recruiting participants at 17 locations. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICANB-002, dose 1

Adeno-associated viral vector carrying the FIX gene single infusion at dose 1.

GENETICANB-002, dose 2

Adeno-associated viral vector carrying the FIX gene single infusion at dose 2.

GENETICANB-002, dose 3

Adeno-associated viral vector carrying the FIX gene single infusion at dose 3.

Locations(17)

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

Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"

Moscow, Russia

LLC "Medis"

Nizhny Novgorod, Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, Russia

Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency

Saint Petersburg, Russia

City Polyclinic №37

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

State Institution "Komi Republican Oncological Dispensary"

Syktyvkar, Russia

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

Ufa, Russia

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NCT06120582

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