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A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)

Trial Profile

A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2025

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary) ; Aspirin
  • Indications Polycythaemia vera
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors PharmaEssentia Corporation

Most Recent Events

  • 13 Aug 2025 Planned End Date changed from 31 Jul 2025 to 31 Jul 2027.
  • 23 Oct 2024 Planned End Date changed from 28 Dec 2025 to 31 Jul 2025.
  • 23 Oct 2024 Planned primary completion date changed from 11 Jan 2024 to 31 Dec 2024.

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