Overview

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A

Status:
Active, not recruiting

Trial end date:
2022-06-30

Target enrollment:

Participant gender:

Summary

This multicenter, open-label, non-randomized study will assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at a dose of 6 milligrams per kilogram (mg/kg) every 4 weeks in participants with hemophilia A with or without inhibitors against factor VIII (FVIII). The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part.

Phase:

Phase 3

Details

Lead Sponsor:

Hoffmann-La Roche

Collaborator:

Chugai Pharmaceutical

Treatments:

Factor VIII