Status:
ACTIVE_NOT_RECRUITING
A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A
Lead Sponsor:
Biocad
Conditions:
Hemophilia A
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-010 in subjects with hemophilia A. The study will have a dose-escalation des...
Detailed Description
The study will be conducted in 2 stages: Stage 1: pilot efficacy and safety study of different doses to select a potentially therapeutic dose for further study. Stage 2: study of the efficacy and sa...
Eligibility Criteria
Inclusion
- 1\. Male subjects aged ≥18 years at the time of signing the informed consent form.
- 3\. Established diagnosis of hemophilia A with a documented history of endogenous FVIII activity ≤1% AND ≤2% at screening.
- 4\. Therapy with FVIII concentrates for at least 150 exposure days.
Exclusion
- History of use of any gene therapy product.
- Use of emicizumab within less than 6 months before the date of signing the ICF.
- The presence of other blood or hematopoietic disorders other than hemophilia A.
- Presence of AAV6 antibodies detected by ELISA.
- BMI \<16 kg/m² or ≥35 kg/m².
- Diagnosis of HIV infection.
- HBV infection.
- HCV infection.
- Any active systemic infections or recurrent infections requiring systemic therapy at screening.
- Any other disorders associated with severe immunodeficiency.
- Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder.
- Malignancies with remission duration of less than 5 years at the time of signing the ICF, except for cured basal cell carcinoma.
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2033
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06185335
Start Date
July 26 2023
End Date
June 1 2033
Last Update
April 24 2025
Active Locations (17)
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1
State Autonomous Institution for Healthcare "Chelyabinsk Regional Clinical Hospital"
Chelyabinsk, Russia, 454048
2
State budgetary healthcare institution Leningrad Regional Clinical Hospital
Gatchina, Russia, 188300
3
Kuzbass Clinical Hospital named after S.V. Belyaev
Kemerovo, Russia, 650066
4
Federal State Budgetary Organization of Science "Kirov Research Institute of Hematology and Blood Transfusions of Federal Medical Biological agency"
Kirov, Russia, 610027