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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

NCT06700096 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Hemophilia B

Interventions

GENETIC

ANB-002

Adeno-associated viral vector carrying the FIX gene single infusion

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Arina Arina V Zinkina-Orikhan · Biocad

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-07
Primary Completion
2027-04-30
Completion
2032-03-31

Countries

  • Russia
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06700096 on ClinicalTrials.gov