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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Jul 2017

At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms CONTI-PV; CONTINUATION-PV; PROUD-PV
  • Sponsors AOP Orphan Pharmaceuticals AG
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 23 Dec 2016 Planned number of patients changed from 130 to 200.
    • 22 Nov 2016 Trial design changed to Randomized and parallel; Number of treatment arms changed from 1 to 2; Standard First Line Treatment (BAT) added in treatments; Time frame for primary endpoint changed from 1.5 years to 3 years.
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