Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

Study Identifier:
ALXN1210-PNH-401
ClinicalTrials.gov Identifier:
EudraCT Identifier:
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
Study Drug
  • Biological: Eculizumab
  • Biological: Ravulizumab
Date
Apr 2021 - Dec 2022
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
Study Drug
  • Biological: Eculizumab
  • Biological: Ravulizumab
Date
Apr 2021 - Dec 2022
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 is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH).

Trial Locations

Location
Status
Location
Clinical Study Site
Leeds, United Kingdom, LS9 7TF
Status
N/A
Location
Research Site
Leeds, United Kingdom, LS9 7TF
Status
N/A
Location
Clinical Study Site
London, United Kingdom, SE5 9RS
Status
N/A
Location
Research Site
London, United Kingdom, SE5 9RS
Status
N/A