Completed PHASE3 INTERVENTIONAL 2-arm NCT01949805

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera (PROUD-PV)

A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera

Sponsor: AOP Orphan Pharmaceuticals AG

Conditions Polycythemia Vera

Interventions Hydroxyurea Peg-P-IFN-alpha-2b (AOP2014)

Updated 6 times since 2017 Last updated: Nov 24, 2016 Started: Sep 30, 2013 Primary completion: Jul 31, 2016 Completion: Jul 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Polycythemia Vera and is currently completed. AOP Orphan Pharmaceuticals AG leads this study, which shows 6 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Sep 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AOP Orphan Pharmaceuticals AG
PharmaEssentia (Co-Sponsor for USA)

Data source: AOP Orphan Pharmaceuticals AG

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Banská Bystrica, Slovakia , Barcelona, Spain , Bonn, Germany , Brasov, Romania , Bratislava, Slovakia , Brno, Czechia , Brussels, Belgium , Bucharest, Romania , Budapest, Hungary and 43 more locations