Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant

Exclusion Criteria

• •1. Thrombotic thrombocytopenic purpura (TTP) evidenced by ADAMTS13 deficiency
• •2. Known Shiga toxin-related hemolytic uremic syndrome as demonstrated by positive test.
• •3. Positive direct Coombs test indicative of a clinically significant immune-mediated hemolysis not due to TMA.
• •4. Clinical diagnosis of disseminated intravascular coagulation (DIC).
• •5. Known bone marrow/graft failure for the current HSCT.
• •6. Diagnosis of veno-occlusive disease which is unresolved at the time of Screening.
• •7. Human immunodeficiency virus (HIV) infection.
• •8. Unresolved meningococcal disease.
• •9. Presence of sepsis requiring vasopressor support.
• •10. Pregnancy or breastfeeding.
• •11. Hypersensitivity to murine proteins or to one of the excipients of ravulizumab.
• •12. Any ongoing or history of medical or psychological conditions unrelated to HSCT-TMA that could increase the risk to the participant or confound the outcome of the study.
• •13. Respiratory failure requiring mechanical ventilation.
• •14. Acute and/or chronic heart failure with an ejection fraction ≤ 40%.
• •15. Previously or currently treated with a complement inhibitor.
• •16. Participation in an interventional treatment study of any therapy for TMA.