Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Phase III study to compare the efficacy and safety of the novel monopegylated interferon
alpha 2b AOP2014 versus Hydroxyurea (the current licensed therapy for this disease). One year
treatment of patients with polycythemia vera. Objective is to demonstrate non-inferiority of
AOP2014 vs. HU in terms of disease response rate in both HU naïve and currently treated
patients, diagnosed with Polycythemia Vera. Response is measured as normalisation of key lab
parameters as well as normalized spleen size.