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A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the Severe Hemophilia A.

RecruitingPhase 1Ages 12 Years - 74 YearsMalePfizer
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In plain words

What the trial is, and whether it could suit you

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 without inhibitors. Hemophilia A is 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 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 withouth inhibitors who are on emicizumab treatment for at least 6 months. * must be 12 to less than 75

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male and 12 to \<75 years of age with a minimum body weight of 35 kg at the time of signing the informed consent. 2. Diagnosis of severe hemophilia A (FVIII activity \<1%) without inhibitors. 3. On emicizumab therapy at a standard clinical dose for ≥6 months. Exclusion Criteria: 1. Previous or current treatment for or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease. 2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 3. Known hemostatic defect other than hemophilia A. 4. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 5. Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study. 6. Platelet count \<100,000/μl or hemoglobin \<10 g/dL. 7. Clinically significant renal or hepatic function abnormality based on laboratory results at screening, or known kidney or liver disease. 8. CD4 cell count ≤200/μl if HIV positive. 9. Screening 12-lead ECG that demonstrates clinically significant abnormalities that, in the opinion of the investigator, may affect participant safety or interpretation of study results. 10. Known planned surgical procedure. 11. Hypersensitivity or allergic reaction to hamster protein or other components of the study intervention. 12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor-delegate employees directly involved in the conduct of the study and their family members.
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What it tests

  • MARSTACIMAB
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Where

10 sites
Altman Clinical and Translational Research Institute-IDS
La Jolla, United States
Altman Clinical and Translational Research Institute
La Jolla, United States
Orthopaedic Institute for Children/Orthopaedic Hemophilia Treatment Center
Los Angeles, United States
UCSD Center for Bleeding and Clotting Disorders
San Diego, United States
Brody School of Medicine at East Carolina University
Greenville, United States
ECU Health Medical Center
Greenville, United States
Nirmal Hospital Pvt Ltd.
Surat, India
K J Somaiya Hospital & Research Centre
Mumbai, India

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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