NCT07457151

Danicopan PMS in Korea

Danicopan Regulatory Post-Marketing Study in Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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. Primary objective(s) To assess the safety of Danicopan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab)in patients with PNH in Korea. Secondary objective(s) To assess effectiveness of Danicopan as add- on therapy to a C5 inhibitor (Eculizumab or Ravulizumab) in patients with PNH at 12 weeks.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Timeline

• Start date: 2026-04-10
• Primary completion: 2028-06-27
• Completion: 2028-06-27
• First posted: 2026-03-09
• Last updated: 2026-04-17

Locations

4 sites across 1 country: South Korea