Comparing ANB-002 to standard treatment for hemophilia B
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
PHASE3 · Biocad · NCT06700096
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.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Biocad (industry) |
| Locations | 14 sites (Chelyabinsk and 13 other locations) |
| Trial ID | NCT06700096 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult men diagnosed with hemophilia B, aged 18 or older, with FIX activity levels of 2% or lower and no FIX inhibitors.
Not a fit: Patients with other blood disorders, active infections, or a history of gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with hemophilia B, potentially improving their quality of life.
How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for hemophilia have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chelyabinsk and 13 other locations
- 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)
- State budgetary healthcare institution Leningrad Regional Clinical Hospital — Saint Petersburg, Russia (RECRUITING)
- Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency — Saint Petersburg, Russia (RECRUITING)
- Almazov National Medical Research Centre — Saint Petersburg, Russia (RECRUITING)
- Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation — Samara, Russia (RECRUITING)
- Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation — Ufa, Russia (RECRUITING)
- King Chulalongkorn Memorial Hospital — Bangkok, Thailand (NOT_YET_RECRUITING)
- Ramathibodi Hospital — Bangkok, Thailand (NOT_YET_RECRUITING)
- Siriraj Hospital — Bangkok, Thailand (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Anna Eremeeva, MD PhD
- Email: eremeevaav@biocad.ru
- Phone: +7 (812) 380 49 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemophilia B