A Study to Learn More About the Safety of Damoctocog-alfa-pegol When Used in Routine Medical Care in Korean Participants With Hemophilia A

Launched by BAYER · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called damoctocog alfa pegol, which helps people with hemophilia A, a genetic disorder that prevents blood from clotting properly. The trial involves Korean participants aged 12 and older who have previously received other treatments for hemophilia A. During the study, researchers will observe how well the medication works in everyday medical care without making any changes to the participants' usual treatments. They will collect information about any health issues that arise while the participants are using the medication, relying on their routine health records and clinic visits.

To join the study, participants must be at least 12 years old, have hemophilia A, and have previously used clotting factor treatments. They will receive damoctocog alfa pegol as prescribed by their doctors, but there will be no extra visits or tests specifically for the study. The data collection will take place from December 2023 to March 2026, with each participant providing information over about 8 months. This trial aims to provide more information about the safety of the medication in real-world settings, which can help improve care for others with hemophilia A in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥12 years of age with hemophilia A
• • 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:
• • Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein))
• • 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