Marstacimab for Hemophilia A
Trial Summary
What is the purpose of this trial?
The purpose of the study is to learn about safety, how the body processes marstacimab and how it works in patients with severe hemophilia A. A rare bleeding disorder where the blood doesn't clot normally. This causes a person to bleed a lot, even from a small cut.These patients can be with or without inhibitors who are on emicizumab medicine for routine prophylaxis for at least 6 months, and desire to switch to marstacimab medicine. Inhibitors are antibodies that the immune system develops because it sees the infused clotting factor as a foreign substance that needs to be destroyed. Antibodies are proteins that eat up the activated factor before it has time to stop the bleeding. Prophylaxis are preventive medicines.This study is seeking for participants:* with severe Hemophilia A who are on emicizumab treatment for at least 6 months.* must be 12 to less than 75 years old* must have a body weight of at least 35 kilograms. The results from this study will serve as a guide to doctors and their hemophilia A patients who will change their medicines in the real-world clinical setting. Patients who can take part in the study will receive marstacimab medicine as weekly injections under the skin of 150 milligrams for 4 months. Study treatment with marstacimab will be initiated no earlier than 14 days after last dose of emicizumab. The study can last up to 6 months. The sponsor will provide marstacimab. Patients will continue their usual treatment with the infused clotting factor for their bleeds when taking part in the study.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for males aged 12 to under 75 with severe Hemophilia A, weighing at least 35 kg. They must have been on emicizumab therapy for routine prophylaxis for over 6 months. It's not specified who can't join the trial.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Wash-out
14-day wash-out period following discontinuation of emicizumab
Treatment
Participants receive marstacimab 150 mg subcutaneous injections once weekly for 4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Marstacimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University