Observing the safety of damoctocog-alfa-pegol in Korean patients with hemophilia A
Post Marketing Surveillance Study for Jivi (Damoctocog Alfa Pegol) in Korean Patients With Hemophilia A
This study is looking at how safe the hemophilia A treatment damoctocog alfa pegol is for Korean patients aged 12 and older who are already using it as part of their regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06222697 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the safety of damoctocog alfa pegol, a treatment for hemophilia A, as it is used in routine medical care among Korean participants. Researchers will monitor participants who are already receiving this treatment as prescribed by their healthcare providers, without altering their treatment plans. The focus is on understanding the real-world safety profile of this medication in patients aged 12 and older who have previously used other hemophilia A treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 and older diagnosed with hemophilia A who have previously been treated with FVIII concentrates.
Not a fit: Patients with other bleeding or coagulation disorders, or those currently undergoing immune tolerance induction treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of damoctocog alfa pegol, potentially leading to improved treatment protocols for hemophilia A.
How similar studies have performed: While this study focuses on real-world safety data, similar observational studies have previously shown success in understanding treatment safety profiles.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Multiple Locations
- Many Locations — Multiple Locations, South Korea (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.