Danicopan Regulatory Post-Marketing Study in Korea
Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Research Site
RECRUITING
Busan
Research Site
NOT_YET_RECRUITING
Daegu
Research Site
NOT_YET_RECRUITING
Hwasun-gun
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2028-06-27
Participants
Target number of participants: 8
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca