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Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Sponsor: Alexion Pharmaceuticals, Inc.
Summary
This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (PNH) in China.
Official title: Open-Label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2023-07-05
Completion Date
2025-04-14
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
Eculizumab
Participants will receive 600 milligrams (mg) once a week on Day 1, 8, 15, and 22 followed by 900 mg every 2 weeks from Day 29 to Day 435.
Locations (7)
Research Site
Beijing, China
Research Site
Hangzhou, China
Research Site
Nantong, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Research Site
Tianjin, China
Research Site
Wuhan, China