At a glance
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A Phase 3, Single-arm, Open-label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
In Brief
A Phase 3 clinical trial evaluating Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria and PNH. Completed, enrolled 18 participants across 8 sites.
Signals
Detailed Summary
The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.
Study Details
Timeline
Arms & Interventions
During the Primary Treatment Period, participants will receive a weight-based loading dose of ravulizumab on Day 1 followed by weight-based maintenance dose of ravulizumab on Day 15 and once every 8 weeks (q8w) thereafter for a total of 26 weeks. On Day 183, all participants will enter a 32-week Extension Treatment Period and receive ravulizumab. Beginning on Day 183, participants will receive a maintenance dose of ravulizumab q8w for an additional 32 weeks.
Interventions
Ravulizumab will be administered by intravenous (IV) infusion.