drugset / Trial / NCT04158648

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

NCT04158648

Phase 3 Completed 73 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

Timeline

Start
2020-02-10
Primary completion
2021-10-30
Completion
2025-12-19

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