Trial Results

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

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

Study Identifier:
ALXN2040-PNH-301
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Danicopan
  • Drug: Placebo
  • Drug: C5 Inhibitor
Date
Dec 2020 - Jun 2022
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: Danicopan
  • Drug: Placebo
  • Drug: C5 Inhibitor
Date
Dec 2020 - Jun 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information

Protocol Summary

The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

Trial Locations

Location
Status
Location
Research Site
Los Angeles, California, United States, 90089
Status
N/A
Location
Research Site
Weston, Florida, United States, 33331
Status
N/A
Location
Research Site
Chicago, Illinois, United States, 60612
Status
N/A
Location
Research Site
Kalamazoo, Michigan, United States, 49007
Status
N/A
Location
Research Site
New York, New York, United States, 10065
Status
N/A
Location
Research Site
Dallas, Texas, United States, 75390
Status
N/A