drugset / Trial / NCT04320602

Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

NCT04320602

Phase 4 Completed 18 enrolled Alexion Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH).

Timeline

Start
2021-04-14
Primary completion
2022-12-20
Completion
2022-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Ravulizumab Monoclonal antibody Intravenous
Background Eculizumab Monoclonal antibody 1200 mg