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Investigating ANB-002 for treating Hemophilia B

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

Phase1; Phase2 Interventional Biocad · NCT06120582

This study is testing a new treatment called ANB-002 to see if it can safely help people with Hemophilia B manage their condition better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment28 (estimated)
Ages18 Years and up
SexMale
SponsorBiocad Industry-sponsored
Locations17 sites (Homyel and 16 other locations)
Trial IDNCT06120582 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to evaluate the safety, immunogenicity, and efficacy of ANB-002 in patients with Hemophilia B through a dose-escalation design. Participants will be divided into cohorts receiving different doses of ANB-002, with follow-up assessments for dose-limiting toxicity over 28 days. An Independent Data Monitoring Committee will oversee the dosing decisions and further enrollment based on safety and efficacy data. The study will also include an exploratory cohort for patients with specific prior conditions.

Who should consider this trial

Good fit: Ideal candidates are adult males with Hemophilia B and low FIX activity who have had significant prior exposure to FIX concentrates.

Not a fit: Patients with previous gene therapy or other significant blood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Hemophilia B and enhance patients' quality of life.

How similar studies have performed: While there have been studies on gene therapies for Hemophilia, this specific approach with ANB-002 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male with hemophilia B.
2. Age ≥18 years.
3. FIX activity at screening ≤2% without FIX inhibitor.
4. ≥150 previous exposure days of treatment with FIX concentrates.

Exclusion Criteria:

1. Previous gene therapy.
2. Other blood or hematopoietic disorders.
3. Positive Anti-AAV5 antibodies (for Cohorts 1-3).
4. Diagnosed HIV-infection, not controlled with anti-viral therapy.
5. Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.
6. Any active systemic infections or recurrent infections requiring systemic therapy at screening.
7. Any other disorders associated with severe immunodeficiency.
8. Significant hepatic disorders (liver cirrhosis, liver fibrosis, etc).
9. Malignancies with remission \<5 years.

Where this trial is running

Homyel and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hemophilia B
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.