MedTrace Logo

Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera

NCT01949805 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2016-11-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

Pegylated interferon alpha 2b given Q2W as SC injection

DRUG

Hydroxyurea

Hydroyurea capsules taken daily po

Sponsors & Collaborators

  • PharmaEssentia (Co-Sponsor for USA)

    collaborator UNKNOWN

  • AOP Orphan Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Heinz Gisslinger, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949805 on ClinicalTrials.gov