Actively Recruiting
A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
Led by Bayer · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study. Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments. Through this study, researchers want to learn more about its safety in a real-world setting. The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information. The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment. Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits. In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
CONDITIONS
Official Title
A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 12 years of age or older with hemophilia A
- Previously treated with factor VIII concentrate (plasma derived or recombinant)
- Currently treated with Jivi (damoctocog alfa pegol) or planned to start treatment as decided by their doctor
- Written informed consent from the participant or legal representative; assent from the participant when appropriate
You will not qualify if you...
- Known allergy or hypersensitivity to damoctocog alfa pegol or its components (e.g., mouse or hamster protein)
- Participation in another investigational program with treatments outside routine clinical care
- Diagnosis of any bleeding or coagulation disorder other than hemophilia A
- Receiving immune tolerance induction treatment at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Many Locations
Multiple Locations, South Korea
Actively Recruiting
Research Team
B
Bayer Clinical Trials Contact
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
1
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