ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study Identifier:
ALXN1210-PNH-301
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Available Documents

Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study Drug
  • Biological: Ravulizumab
  • Biological: Eculizumab
Date
Dec 2016 - Feb 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A+ years
Requirements Information
Sex
Female & Male
Age
N/A+ years

Study Details

Medical Condition
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study Drug
  • Biological: Ravulizumab
  • Biological: Eculizumab
Date
Dec 2016 - Feb 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A+ years years
Requirements Information

Protocol Summary

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).

Trial Locations

Location
Status
Location
Research Site
Los Angeles, California, United States, 90033
Status
N/A
Location
Research Site
Whittier, California, United States, 90603
Status
N/A
Location
Research Site
Fort Worth, Texas, United States, 76104
Status
N/A
Location
Research Site
Buenos Aires, Argentina, C1015ABO
Status
N/A
Location
Research Site
Córdoba, Argentina, X5004BAL
Status
N/A
Location
Research Site
Perth, Australia, 6000
Status
N/A