RecruitingPhase 3NCT06700096
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B
Sponsor
Biocad
Enrollment
24 participants
Start Date
Nov 7, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria9
- 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
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Interventions
GENETICANB-002
Adeno-associated viral vector carrying the FIX gene single infusion
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06700096
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