Actively Recruiting

Age: 12Years +
All Genders
NCT06992076

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-04-29

100

Participants Needed

2

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with hemophilia A or hemophilia B and eligible for prophylaxis treatment
  • Prescribed marstacimab for routine prophylaxis by a clinical physician according to approved guidelines
  • Aged 12 years or older (adolescents 12 to less than 18 years, adults 18 years and older)
  • Signed informed consent provided by participant or legally authorized representative
Not Eligible

You will not qualify if you...

  • Unable to complete at least one month of follow-up as judged by the investigator
  • Severe speech, vision, memory, or cognitive impairment affecting communication or ability to complete questionnaires and visits
  • Women of childbearing age planning pregnancy within 2 months, pregnant, or breastfeeding
  • Currently participating in other clinical trials
  • Any other condition deemed unsuitable for participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Actively Recruiting

2

Institute of haematology and Blood diseases hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

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Research Team

R

renchi yang, MD

CONTACT

F

feng xue, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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