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Not yet recruiting NCT07282132

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

— Observational Polycytemia Vera

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropeginterferon alfa-2b (BESREMi®).
Who it may be relevant to
Registry conditions: Polycytemia Vera. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multicenter Insights on Real-World Results Of Ropeginterferon Alpha-2B in Polycythemia Vera Patients

Overview

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.

Interventions

  • Drug Ropeginterferon alfa-2b (BESREMi®)
    Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information.

Primary outcome measures

  • Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera [Time frame: From enrollment to the end of treatment or at least 12 months of treatment]
Secondary outcome measures (9)
  • Time to Hematologic Response [Time frame: Baseline to first documented CHR or PR (up to 24 months)]
  • Duration of Hematologic Response [Time frame: From first CHR/PR to loss or last follow-up (up to 24 months)]
  • Progression-Free Survival (PFS) [Time frame: Baseline to event or last follow-up (up to 24 months)]
  • Thromboembolic Event Rate [Time frame: Baseline to last follow-up (up to 24 months)]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: Baseline to last follow-up (up to 24 months)]
  • Treatment Discontinuation [Time frame: Baseline to last follow-up (up to 24 months)]
  • Dose Modifications and Adherence [Time frame: Baseline to last follow-up (up to 24 months)]
  • Normalization of Hematologic Parameters [Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)]
  • JAK2 V617F Allele Burden [Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Have signed informed consent for participation.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07282132 · AIFA-RSO-3948 · AIFA-RSO-3948

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗