NCT05987449

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 2 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors. The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	NXT007	Participants will receive NXT007 administered subcutaneously (SC), 2 loading doses once every two weeks (Q2W) followed by once every 4 weeks (Q4W) maintenance doses based on the schedule.

Timeline

• Start date: 2023-09-21
• Primary completion: 2030-06-16
• Completion: 2030-06-16
• First posted: 2023-08-14
• Last updated: 2026-04-06

Locations

14 sites across 6 countries: United States, Canada, Italy, New Zealand, Poland, Spain

Regulatory

• FDA-regulated drug study