PIII PROUD-PV study (n=257) is published in the NEJM; treatment with ropeginterferon alfa-2b did not show non-inferiority compared to treatment with hydroxycarbamide: 21% vs 28% respectively met the composite primary endpoint of complete haematological response with normal spleen size. The extension study, CONTINUATION-PV, is ongoing .
PIII open label PEN-PV trial started to evaluate self-administration of a subcutaneous injection of ropeginterferon alfa-2b 0.5 mg/ml using pre-filled pen in patients with polycythaemia vera (NCT02523638; EudraCT2014-001356-31). Primary endpoint is ease of self-administration every 14 days evaluated using dedicated questionnaires. The trial is recruiting 30 patients in Hungary, Austria, Bulgaria, Czech Republic, France, Poland, Slovakia and Ukraine. Study completion Dec 15 .
Recruitment of 260 treatment experienced or naive pts into pivotal Phase III Trial PROUD-PV [NCT01949805] complete. PROUD-PV is a randomised, open-label, multicentre, controlled, parallel arm, PIII study assessing the efficacy and safety of Ropeginterferon alfa-2b vs. hydroxyurea in Patients with Polycythemia Vera. The primary endpoint is a composite endpoint of hematocrit, platelets, leukocytes, and spleen size at 12 months. Disease response rate is defined as haematocrit <45% without phlebotomy (at least 3 months since last phlebotomy), platelets <400 G/L, leukocytes <10 G/L , and normal spleen size. The estimated primary completion date of PROUD-PV is September 2015 [2,3].