NCT06992076Recruiting
Adult and Adolescent Hemophilia Patients Treated With Marstacimab: a Patient Experience Registry
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 May 2025
- Start date
- 15 Feb 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Haemophilia
- NCT number
- NCT06992076
What you commit to
- Study type: Observational
- Planned participants: 100
- From 15 Feb 2026 to the primary completion date, 31 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe impairment of speech, vision, memory or cognition that affects communication and ability to complete questionnaires and follow-up visits.
- Patients are participating in other clinical trials. There are other conditions that the investigator deems unsuitable for participation in this study.
Age
- Women of childbearing age who plan to become pregnant within the next 2 months, as well as women who are pregnant or breastfeeding.
Other
- \- Those who are unable to complete at least one month follow-up based on the investigator's judgment.
Who the study is looking for
- \- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of haematology and Blood diseases hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.