Safety and Effectiveness Study of Danicopan Added to Eculizumab or Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria in Korea

What this Trial Is About

This research aims to assess the safety and effectiveness of Danicopan when added to C5 inhibitors Eculizumab or Ravulizumab in patients with Paroxysmal Nocturnal Hemoglobinuria PNH in Korea. It is conducted as a post-approval commitment to characterize the known safety profile and detect any unexpected adverse reactions in routine clinical practice. Participants will receive Danicopan as an add-on therapy to their existing treatment with either Eculizumab or Ravulizumab. The study observes patients under normal medical care conditions without altering their treatment plans. Data on safety will be collected for up to 12 weeks from the first dose, and effectiveness will be evaluated at 12 weeks or at the end of treatment if discontinued earlier. During the study, participants will be monitored for adverse events, serious adverse events, and other safety concerns. Effectiveness assessments include changes in hemoglobin levels, reticulocyte counts, fatigue scores, and the proportion of patients avoiding red blood cell transfusions. The total participation duration is up to 12 weeks, with data gathered from routine clinical visits and patient records.

Danicopan PMS in Korea