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drugset / Trial / 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

NCT05181618 ↗

Phase 4 Active not recruiting 136 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelBasic science

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.

Timeline

Start
2022-06-20
Primary completion
2026-12-04
Completion
2027-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Emicizumab Monoclonal antibody 1.5 mg/kg Subcutaneous
Subject Emicizumab Monoclonal antibody 3 mg/kg Subcutaneous
Subject Emicizumab Monoclonal antibody 6 mg/kg Subcutaneous

Indications

moderately severe hemophilia A severe hemophilia A