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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

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

Completed
Phase of Trial: Phase I/II

Latest Information Update: 20 Feb 2019

At a glance

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

    • 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.
    • 04 Dec 2018 Results evaluating safety and efficacy of Ropeginterferon alfa-2b in patients with polycythemia vera presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 29 Jan 2018 Status changed from active, no longer recruiting to completed.
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