Comparing ANB-002 to standard treatment for 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 study aims to evaluate the efficacy and safety of a single dose of ANB-002 in adult patients with hemophilia B, specifically those with low FIX activity and no FIX inhibitors. Participants will first undergo a non-interventional lead-in period receiving standard FIX treatment for at least six months before switching to the investigational product ANB-002. The main interventional period will last 18 months, followed by a follow-up period of up to five years to assess long-term outcomes. The study is designed to demonstrate that ANB-002 is non-inferior to standard treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Anti-AAV5 antibodies
* Any active systemic infections or recurrent infections requiring systemic therapy
* Any other disorders associated with severe immunodeficiency
* Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder
* Malignancies with less than 5 years of remission

Where it's running

• Chelyabinsk Regional Clinical Hospital
  Chelyabinsk, Russia Recruiting
• Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
  Kirov, Russia Recruiting
• 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 Recruiting
• 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 Recruiting
• Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
  Moscow, Russia Recruiting
• State Novosibirsk Regional Clinical Hospital
  Novosibirsk, 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.

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• Gene therapy for treating hemophilia B

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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.