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 126 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 inhibitors. The study will include people aged ≥12 years old with severe or moderate congenital hemophilia A without inhibitors on previous FVIII prophylaxis treatment.

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