Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants with PNH Who Have Clinically Significant Extravascular Hemolysis

Exclusion Criteria

• - Platelet count < 30000/μL or there is a need for platelet transfusions.
• - ANC < 500/μL.
• - Clinically significant laboratory abnormalities related to liver function, including:
• • ALT > 2 × ULN or ALT > 3 × ULN for participants with documented liver iron overload defined by serum ferritin values ≥ 500 ng/mL.
• • Direct bilirubin > 2 × ULN, unless, in the Investigator's opinion, is due to hemolysis or Gilbert’s syndrome based on medical history.
• - Current evidence of biliary cholestasis.
• - Known aplastic anemia or other bone marrow failure that requires HSCT or other therapies, including anti-thymocyte globulin and immunosuppressants unless the dosage of immunosuppressant has been stable for at least 12 weeks before Day 1 and is expected to remain stable through Week 12.
• - History of a major organ transplant (eg, heart, lung, kidney, liver) or HSCT.
• - Known or suspected complement deficiency.
• - Active bacterial or viral infection, a body temperature > 38°C on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to first study intervention administration.