Emicizumab for Hemophilia A
(HAVEN 6 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on any investigational drugs or treatments for hemophilia, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Emicizumab for Hemophilia A?
Is emicizumab safe for humans?
How is the drug Emicizumab different from other treatments for Hemophilia A?
Emicizumab is unique because it is a bispecific antibody that mimics the function of missing factor VIII by bridging activated factor IX and factor X, helping to prevent bleeding in Hemophilia A patients. Unlike traditional treatments that require intravenous infusions, Emicizumab is administered subcutaneously (under the skin), making it more convenient for patients.128910
What is the purpose of this trial?
This trial tests emicizumab, a medication that helps blood clot, in people with mild or moderate hemophilia A. It works by mimicking a missing protein to improve blood clotting. Emicizumab has been approved for treatment of hemophilia A patients.
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for individuals with mild or moderate Hemophilia A without inhibitors to factor VIII. Participants must weigh at least 3 kg, need prophylaxis, have documented treatment and bleeding episodes history, and proper organ function. Women of childbearing age should agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive emicizumab with a loading dose regimen followed by one of three maintenance dose regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants continue to be monitored for long-term safety and efficacy outcomes
Treatment Details
Interventions
- Emicizumab
Emicizumab is already approved in United States, European Union for the following indications:
- Hemophilia A
- Hemophilia A with inhibitors
- Hemophilia A
- Hemophilia A with inhibitors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University