Danicopan PMS in Korea
Danicopan Regulatory Post-Marketing Study in Korea
AstraZeneca
8 participants
Apr 10, 2026
OBSERVATIONAL
Conditions
Summary
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Danicopan as an add-on to ravulizumab or eculizumab in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Danicopan under conditions of routine daily medical practice in Korea.
Eligibility
Inclusion Criteria2
- Patients eligible for and treated with Danicpan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab) in patient with PNH in Korea
- Provision of a signed and dated written informed consent by the patient or their legally acceptable representative
Exclusion Criteria2
- Participation in any concurrent interventional trials during the period of study drug treatment
- Other off-label indications according to the approved label in Korea
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07457151