Actively Recruiting
Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A
Led by Bayer · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the safety of damoctocog alfa pegol, a medicine used to treat hemophilia A, a genetic bleeding disorder caused by missing clotting factor 8 (FVIII). This study focuses on Korean participants who are at least 12 years old and have previously used other hemophilia A treatments. The main goal is to learn more about the safety of this medicine when used in routine medical care. Participants receive damoctocog alfa pegol as prescribed by their doctors following usual clinical practices. The study does not provide the medicine directly, and no changes to healthcare or additional treatments are made for study purposes. Data collection happens continuously during a 36-week period as participants continue their regular clinic visits. During the study, researchers collect data from participants' health records and routine care without requiring extra visits or tests. They monitor for any medical problems, including adverse events, serious adverse events, and reactions related to the treatment. The study tracks bleeding episodes, medicine usage, and treatment choices over about eight months for each participant, providing real-world safety information.
CONDITIONS
Brief 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...
- Age 12 years or older with hemophilia A
- Previously treated with factor VIII concentrates (plasma derived or recombinant)
- Treated with Jivi (damoctocog alfa pegol) or decision made to start Jivi as per physician's usual practice
- Provided written informed consent or assent when appropriate
You will not qualify if you...
- Contraindications according to local approved use, including known allergies to the drug or its components (e.g., mouse or hamster protein)
- Participation in other investigational programs with treatments outside routine care
- Any bleeding or coagulation disorder other than hemophilia A
- Currently receiving immune tolerance induction treatment at enrollment
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.
1 visit (in-person)
Duration - Up to 36 weeks
Participants who undergo routine care with Damoctocog-alfa-pegol are observed over a 36-week period for safety and treatment outcomes.
Participants follow their usual medical visits with data collected continuously during this period
Trial Site Locations
Total: 1 location
1
Many Locations
Multiple Locations, South Korea
Actively Recruiting
Research Team
B
Bayer Clinical Trials 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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