Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFederico II University

About this trial

This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV). Eligible patients have a confirmed PV diagnosis according to current criteria, have received at least one dose of Ropeginterferon, and have complete clinical and laboratory data available. The primary objective is to analyze the time course of hematologic response (complete or partial, CHR/PR) according to ELN criteria, and to identify clinical and treatment-related factors associated with achieving and maintaining response. Secondary objectives include time to response, duration of response, progression-free survival, thromboembolic event rate, safety and tolerability, treatment discontinuation, dose modifications and adherence, normalization of hematologic parameters, and changes in JAK2 V617F allele burden. Data will be collected retrospectively from medical records at participating centers.

Eligibility criteria

Qualifiers

Confirmed diagnosis of Polycythemia Vera according to updated diagnostic criteria

Have received at least one dose of Ropeginterferon Alfa-2b (BESREMI).

Complete clinical and laboratory data availability for review (e.g., hematologic parameters, treatment response, adverse events).

Followed at one of the participating study centers.

Disqualifiers

Have received experimental or non-approved treatments for PV during the observation period.

Lack sufficient clinical or laboratory data to allow inclusion in the analysis.

Trial design

Treatments tested in this trial

  • Ropeginterferon alfa-2b (BESREMi®)

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators