Status:
RECRUITING
Danicopan PMS in Korea
Lead Sponsor:
AstraZeneca
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
Brief 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 e...
Detailed Description
The objectives of this study are to assess the safety and effectiveness of Danicopan in a real world setting in patients who are prescribed with the study drug under the approved indication in Korea. ...
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Participation in any concurrent interventional trials during the period of study drug treatment
- Other off-label indications according to the approved label in Korea
Key Trial Info
Start Date :
April 10 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 27 2028
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT07457151
Start Date
April 10 2026
End Date
June 27 2028
Last Update
April 17 2026
Active Locations (4)
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1
Research Site
Busan, South Korea
2
Research Site
Daegu, South Korea
3
Research Site
Hwasun-gun, South Korea
4
Research Site
Seoul, South Korea