NCT07416526

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

A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Factor VIII Prophylaxis in People With Hemophilia A Without Inhibitors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NXT007	NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
DRUG	Human Coagulation Factor VIII	Factor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice.

Timeline

• Start date: 2026-05-09
• Primary completion: 2027-09-23
• Completion: 2031-09-23
• First posted: 2026-02-18
• Last updated: 2026-04-13

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study