NCT06700096RecruitingPhase 3
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 7 Nov 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Biocad
- Diseases
- Haemophilia
- NCT number
- NCT06700096
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 24
- From 7 Nov 2024 to the primary completion date, Apr 2027
- 14 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anti-AAV5 antibodies
Other illness
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chelyabinsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Recruiting |
| Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency" Coordinator of this site? Confirm its status | Kirov | Russia | Recruiting |
| Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin" Coordinator of this site? Confirm its status | Moscow | 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) Coordinator of this site? Confirm its status | 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) Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| State Novosibirsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
| Almazov National Medical Research Centre Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency Coordinator of this site? Confirm its status | 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 Coordinator of this site? Confirm its status | Samara | Russia | Recruiting |
| Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation Coordinator of this site? Confirm its status | Ufa | Russia | Recruiting |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.