Observing the safety of damoctocog-alfa-pegol in Korean patients with hemophilia A

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.