NCT06578949

Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria
• PNH

Interventions

Type	Name	Description
DRUG	Ravulizumab	Ravulizumab will be administered by intravenous (IV) infusion.

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-05-15
• Completion: 2025-12-22
• First posted: 2024-08-30
• Last updated: 2026-01-21

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated drug study