Condition: Hemophilia · Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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. Exploratory Objectives: To evaluate the annualized bleeding rate (ABR) of different types of bleeds after 6 months of subcutaneous marstacimab injections in hemophilia patients. To assess changes in joint status scores between baseline and the final visit after 6 months of subcutaneous marstacimab injections in hemophilia patients, using the Hemophilia Early Arthropathy Detection with Ultrasound in China (HEAD-US-C). To evaluate patient preferences regarding treatment experience via M-PPQ after 6 months
This description comes directly from the study's public registry record.
renchi yang, MD · 022-23608174 · yangrenchi@ihcams.ac.cn
feng xue, MD · 022-23608174 · xuefeng@ihcams.ac.cn
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| The First Affiliated Hospital of Xiamen University | Xiamen, Fujian, China | Recruiting |
| Institute of haematology and Blood diseases hospital | Tianjin, Tianjin Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06992076