drugset / Trial / NCT07416526

A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A

NCT07416526 ↗

Phase 3 Recruiting 138 enrolled Hoffmann-La Roche Chugai Pharmaceutical · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.

Timeline

Start
2026-05-15
Primary completion
2027-09-23
Completion
2031-09-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Human Coagulation Factor VIII Protein / enzyme biologic — —
Subject NXT007 Unknown — Subcutaneous

Indications