Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Study Identifier:
D7414C00001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Jul 2023 - Apr 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Eculizumab
Date
Jul 2023 - Apr 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Research Site
Beijing, China, CN-100730
Status
N/A
Location
Research Site
Hangzhou, China, 310003
Status
N/A
Location
Research Site
Nantong, China, 226001
Status
N/A
Location
Research Site
Shanghai, China, 200040
Status
N/A
Location
Research Site
Tianjin, China, 300020
Status
N/A
Location
Research Site
Tianjin, China, 300050
Status
N/A