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Adult and Adolescent Hemophilia Patients Treated With Marstacimab: a Patient Experience Registry

Recruitingn/aAges 12 Years - anyAllInstitute of Hematology & Blood Diseases Hospital…
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In plain words

What the trial is, and whether it could suit you

Research Title:Adult and adolescent hemophilia patients treated with Marstacimab: a patient Experience Registry (AMBER) Protocol Number:94250855 Protocol Version Number:version 0.3 Date:15-November-2024 Leading site:Institution of Hematology \& Blood Diseases Hospital, Chinese Academy of Medical Sciences Active Pharmaceutical Ingredient:a human IgG1 monoclonal antibody that targets the tissue factor pathway inhibitor (TFPI) Drug Name Generic name: marstacimab-hncq Purpose of the Study Primary Objectives:To quantify patient preferences for subcutaneous versus intravenous (IV) injection using the Marstacimab-Patient Preference Questionnaire (M-PPQ) after 1 month of marstacimab for routine prophylaxis treatment. To assess the treatment burden using the Hemophilia Treatment Experience Measure (Hemo-TEM) in hemophilia patients after 6 months of marstacimab for routine prophylaxis treatment.

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📋 Eligibility rules (as published)
Inclusion Criteria: \- Participants with a diagnosis of hemophilia A or hemophilia B eligible to receive prophylaxis. Clinical physicians prescribe marstacimab for routine prophylaxis treatment of hemophilia patients based on the actual conditions of the patients and in accordance with the approved indications of marstacimab. Adolescent patients(12 to less than 18 years) and adult (18 years and older) patients. Signed consent obtained before the study, participant or legally authorized representative, or participant's caregiver capable of giving signed informed consent. Exclusion Criteria: \- Those who are unable to complete at least one month follow-up based on the investigator's judgment. Severe impairment of speech, vision, memory or cognition that affects communication and ability to complete questionnaires and follow-up visits. Women of childbearing age who plan to become pregnant within the next 2 months, as well as women who are pregnant or breastfeeding. Patients are participating in other clinical trials. There are other conditions that the investigator deems unsuitable for participation in this study.
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What it tests

  • Marstacimab
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Where

2 sites
The First Affiliated Hospital of Xiamen University
Xiamen, China
Institute of haematology and Blood diseases hospital
Tianjin, China
🤝 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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