drugset / Trial / NCT06120582
Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)
Non-randomizedSequentialOpen-labelTreatment
Summary
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia В. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.
Timeline
- Start
- 2023-05-02
- Primary completion
- 2025-11
- Completion
- 2029-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | arvenacogene sanparvovec | Gene therapy (AAV / viral vector) | — | Intravenous |