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A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Trial Profile

A Phase 3, Randomized, Multicenter, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2024

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At a glance

  • Drugs Pegcetacoplan (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms PRINCE
  • Sponsors Apellis Pharmaceuticals

Most Recent Events

  • 08 May 2024 According to an Sobi media release, the company announced that the European Commission (EC) has approved an indication extension for Aspaveli(pegcetacoplan) for treatment of adult patients with paroxysmal nocturnal haemoglobinuria, who have haemolytic anaemia, based on data from this trial.
  • 12 Dec 2023 Results of an integrated analysis assessing long-term efficacy and safety of pegcetacoplan for PNH treatment from following clinical trials: PEGASUS, PRINCE and their extension trials presented at the 65th American Society of Hematology Annual Meeting and Exposition
  • 11 Dec 2023 According to an Apellis Pharmaceuticals media release, post hoc data from PEGASUS and PRINCE studies and the long-term extension study that reinforce the long-term efficacy and safety of EMPAVELI were presented during an oral presentation at the American Society of Hematology (ASH) Annual Meeting.

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