drugset / Trial / NCT06700096

An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

NCT06700096 ↗

Phase 3 Recruiting 24 enrolled Biocad
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-07
Primary completion
2027-04
Completion
2032-03

Drugs

EvaluationDrugModalityDoseRoute
Subject arvenacogene sanparvovec Gene therapy (AAV / viral vector) — —

Indications