Actively Recruiting
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
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on adults and adolescents diagnosed with hemophilia A or B who are treated with marstacimab, a human monoclonal antibody targeting the tissue factor pathway inhibitor (TFPI). The study aims to understand patient preferences and treatment burden related to marstacimab when used as routine prophylaxis. Researchers also explore outcomes such as annual bleeding rates and joint status changes over a six-month period. The study is observational and sponsored by the Institute of Hematology & Blood Diseases Hospital in China. Participants receive marstacimab through subcutaneous injections, starting with a loading dose of 300 mg on the first day (divided into two 150 mg injections). From the second week onward, patients receive 150 mg once weekly. The study includes three key visits: the initial administration day, a follow-up at about 30 days, and another at around 180 days. Throughout, treatment adherence and administration details are recorded. During the study, patients complete questionnaires assessing their preferences for subcutaneous versus intravenous injections and the treatment burden after 1 and 6 months of marstacimab use. Researchers also monitor bleeding rates and joint health using ultrasound. The study involves regular follow-ups over six months to evaluate these outcomes, ensuring a comprehensive understanding of patient experiences and clinical effects while on marstacimab.
CONDITIONS
Brief Title
Adult and Adolescent Hemophilia Patients Treated With Marstacimab: a Patient Experience Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants diagnosed with hemophilia A or hemophilia B eligible for prophylaxis
- Clinical physicians prescribe marstacimab for routine prophylaxis based on patient condition and approved indications
- Adolescents aged 12 to less than 18 years and adults aged 18 years and older
- Signed informed consent obtained from participant, legal representative, or caregiver
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 and follow-up
- Women of childbearing age planning pregnancy within 2 months, pregnant, or breastfeeding
- Participation in other clinical trials
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 6 months
Participants receive marstacimab with a loading dose on Day 1 followed by weekly injections starting Day 8. Treatment adherence and dosing are recorded.
3 visits: at first administration, 30 days (±7 days), and 180 days (±30 days) after treatment start
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
Research Team
R
renchi yang, MD
F
feng xue, MD
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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