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An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 and standard first line treatment (BAT) in patients with Polycythemia Vera who previously participated in the PROUD-PV Study

Trial Profile

An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 and standard first line treatment (BAT) in patients with Polycythemia Vera who previously participated in the PROUD-PV Study

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

Latest Information Update: 09 Oct 2019

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms CONTI-PV; Continuation; CONTINUATION-PV
  • 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 Feb 2019 Planned End Date changed from 1 Jun 2019 to 1 Mar 2020.
    • 04 Feb 2019 Planned primary completion date changed from 1 Jun 2019 to 1 Mar 2020.
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