An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
NCT ID: NCT06700096
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
24 participants
INTERVENTIONAL
2024-11-07
2032-03-31
Brief Summary
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Detailed Description
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After completiong the lead-in period subjects will enter the main (interventional) period.
At the first visit of the main period subjects will recieve investigational product ANB-002.
The main period ends 18 months after the administration of ANB-002, after which subjects will switch to the follow-up period and will be evaluated up to 5 years after the ANB-002 infusion.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lead-in
All subjects will be enrolled in the Lead-in period in order to collect information on individual bleeding rate anf FIX concentrates consumption
No interventions assigned to this group
ANB-002 (arvenacogene sanparvovec)
After completion of lead-in period subjects will enter the main period which starts with ANB-002 (arvenacogene sanparvovec) infusion.
ANB-002
Adeno-associated viral vector carrying the FIX gene single infusion
Interventions
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ANB-002
Adeno-associated viral vector carrying the FIX gene single infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FIX activity ≤2%
* Absense of FIX inhibitor
* ≥150 previous exposure days of treatment with FIX concentrates
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Arina Arina V Zinkina-Orikhan
Role: STUDY_DIRECTOR
Biocad
Locations
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Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , Russia
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, , Russia
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
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
Federal Budgetary Institution "Moscow City Clinical Hospital named after S. P. Botkin"
Moscow, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency
Saint Petersburg, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation
Samara, , Russia
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation
Ufa, , Russia
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANB-002-2
Identifier Type: -
Identifier Source: org_study_id
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