NCT05181618

A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

A Multicenter, Open-Label Phase IV Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes, in Participants Aged ≥13 and <70 Years With Severe or Moderate Hemophilia A Without FVIII Inhibitors on Emicizumab Prophylaxis

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 13 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and \<70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study.

Conditions

• Severe Hemophilia A
• Moderate Hemophilia A

Interventions

Type	Name	Description
DRUG	Emicizumab	The emicizumab dosing regimen will be 3 milligrams per kilogram of body weight (mg/kg) subcutaneously (SC) once a week (QW) for 4 weeks followed by participant preference of one of the following maintenance regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W) in agreement with the investigator.

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-12-04
• Completion: 2027-05-21
• First posted: 2022-01-06
• Last updated: 2026-01-26

Locations

28 sites across 12 countries: United States, Brazil, Canada, Germany, Hungary, Italy, Morocco, Serbia, Spain, Tunisia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study