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An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera

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Trial Profile

An Open-label, Prospective, Multicentre, Phase I/II Dose Escalation Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Efficacy of P1101, PEG-Proline-Interferon Alpha-2b in Patients With Polycythaemia Vera

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 29 Nov 2021

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Polycythaemia vera
  • Focus Adverse reactions
  • Acronyms PEGINVERA
  • Sponsors AOP Orphan Pharmaceuticals AG

    • Most Recent Events

    • 12 Nov 2021 According to a PharmaEssentia Corporation media release, the U.S. Food and Drug Administration (FDA) has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera (PV), based on safety from the PEGINVERA and PROUD/ CONTINUATION-PV studies and efficacy data from the PEGINVERA clinical study program.
    • 19 Aug 2020 Results (n=149) assessing influence of IFNL4 polymorphisms on HR and MR in PV therapy within (PROUD-PV (NCT01949805), CONTINUATION-PV (NCT02218047) & PEGINVERA (NCT01193699)) studies, published in the Blood.
    • 20 Feb 2019 According to an AOP Orphan Pharmaceuticals AG media release, the European Commission (EC) has granted Marketing Authorization for BESREMi (Ropeginterferon alfa-2b) as first line monotherapy in adults for the treatment of Polycythaemia Vera (PV) without symptomatic splenomegaly. The EC approval was based on data generated in the clinical development program, comprising of pivotal PROUD-PV, PEN-PV, PEGINVERA and the ongoing trial CONTINUATION-PV.
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