Investigating ANB-002 for treating Hemophilia B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Republican Scientific and Practical Center for Radiation Medicine and Human Ecology
  Homyel, Belarus Recruiting
• Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
  Minsk, Belarus Recruiting
• State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital"
  Chelyabinsk, Russia Recruiting
• State budgetary healthcare institution Leningrad Regional Clinical Hospital
  Gatchina, Russia Recruiting
• Kuzbass Clinical Hospital named after S.V. Belyaev
  Kemerovo, Russia Recruiting
• Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
  Kirov, Russia Recruiting

Study contacts

• Study coordinator: Anna Eremeeva, MD PhD
• Email: eremeevaav@biocad.ru
• Phone: +7 (812) 380 49 34

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SR604: a new treatment tested in adults with Hemophilia A/B or congenital Factor VII deficiency

  This study tests a single and multiple doses of SR604 to see if it is safe and effective for adults with Hemophilia A or B, with or without inhibitors, and for those with congenital Factor VII deficiency.

  Recruiting at 7 sites Phase 1/2 Shanghai RAAS Blood Products Co., Ltd. · Changsha and 8 other locations · NCT07644832

• Single-dose CSL222 gene therapy for adolescent males (12–17) with severe or moderately severe hemophilia B.

  This will give a single dose of CSL222 gene therapy to adolescent males with severe or moderately severe hemophilia B to see if it raises factor IX activity and reduces bleeding.

  Recruiting at 17 sites Phase 3 CSL Behring · Orange, California and 16 other locations · NCT07080905

• ATHNdataset registry for people with bleeding and clotting disorders

  This registry collects health, treatment, and patient-reported information from people with bleeding and clotting disorders seen at ATHN-affiliated centers to help improve care and outcomes.

  Recruiting American Thrombosis and Hemostasis Network · Hickory, North Carolina · NCT06820515

• Is synovial proliferation in haemophilia joints active or inactive?

  This project will test whether ultrasound, MRI and elastography can tell if subclinical synovial proliferation in people with severe haemophilia is currently active so clinicians can treat earlier.

  Recruiting UMC Utrecht · Utrecht · NCT06809972

• Observational study of blood clotting and bleeding disorders in Chinese patients

  This study looks at blood clotting and bleeding problems in Chinese patients to see how common they are and what factors might affect them.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality and 4 other locations · NCT06727669

• Comparing ANB-002 to standard treatment for hemophilia B

  This study is testing a new treatment called ANB-002 to see if it works as well as the standard treatment for adults with hemophilia B who have low FIX activity and no FIX inhibitors.

  Recruiting at 11 sites Phase 3 Biocad · Chelyabinsk and 13 other locations · NCT06700096

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.