A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A
NCT ID: NCT06222697
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-01-24
2028-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post-marketing surveillance cohort
Participants follow their usual medical visits with data collection occurs continuously in a 36-week observational period.
Damoctocog-alfa-pegol (Jivi, BAY94-9027)
Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.
Interventions
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Damoctocog-alfa-pegol (Jivi, BAY94-9027)
Follow clinical practice/administration. No drug is provided to participants due to the observational nature of the study.
Eligibility Criteria
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Inclusion Criteria
* Previously treated with FVIII concentrate(s) (plasma derived or recombinant)
* Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.)
* Written informed consent from subject or legal representative; assent from subject when appropriate
Exclusion Criteria
* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia A
* Patients on immune tolerance induction treatment at the time of enrollment
12 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , South Korea
Countries
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Central Contacts
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Related Links
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Click here for access to information about Bayer's transparency standards and Bayer studies.
Other Identifiers
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21278
Identifier Type: -
Identifier Source: org_study_id
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