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A Phase 3 Open-Label Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Significant Extravascular Hemolysis

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Trial Profile

A Phase 3 Open-Label Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Significant Extravascular Hemolysis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2025

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At a glance

  • Drugs Danicopan (Primary) ; Eculizumab (Primary) ; Ravulizumab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexion AstraZeneca Rare Disease

    • Most Recent Events

    • 07 Mar 2025 Planned End Date changed from 12 Jan 2028 to 25 Feb 2028.
    • 07 Mar 2025 Planned primary completion date changed from 30 Dec 2026 to 12 Feb 2027.
    • 07 Mar 2025 Planned initiation date changed from 15 Jan 2025 to 28 Feb 2025.

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