What is damoctocog alfa pegol studying for hemophilia A?

This study is looking at how safe damoctocog alfa pegol is when used by people with hemophilia A in everyday medical care. Researchers want to understand any medical problems that might happen during treatment. The study is sponsored by Bayer and helps provide real-world safety information.

Who may be eligible for this hemophilia A clinical trial?

People aged 12 years or older with hemophilia A who have used factor VIII treatments before may be eligible. There is no gender restriction. Participants cannot be on immune tolerance induction treatment or part of other investigational programs. Please review eligibility criteria for more details.

Is there any cost to participate in this hemophilia A clinical trial?

Study-related care, including the medication and all trial visits, is provided at no cost. However, personal travel and other expenses may not be covered and can vary. Participants should plan accordingly for any such costs.

Actively Recruiting

Age: 12Years +

All Genders

ID06222697

Post Marketing Surveillance Study for Jivi Damoctocog Alfa Pegol in Korean Patients With Hemophilia A

Led by Bayer · Updated on 2026-04-15

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 12Years +

All Genders

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

Research Team

Bayer Clinical Trials Contact

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