Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis

Study Identifier:
D7332C00006
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Danicopan
Date
Feb 2025 - Feb 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 17 Years
Requirements Information
Sex
Female & Male
Age
12 - 17 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Danicopan
Date
Feb 2025 - Feb 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 12 - 17 Years years
Requirements Information

Protocol Summary

The primary objective of this study is to evaluate efficacy of danicopan as add-on treatment to ravulizumab or eculizumab as assessed by hemoglobin (Hgb) change from Baseline at Week 12 in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH) and clinically significant extravascular hemolysis (CS-EVH).

Trial Locations

Location
Status
Location
Research Site
Paris, France, 77019
Status
Recruiting