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NCT Number: NCT07282132

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

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.

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Key information

Conditions

Polycytemia Vera

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropeginterferon alfa-2b (BESREMi®)

Drug

Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information.

Primary outcomes

  1. 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

    Definition: Proportion of patients achieving Complete Hematologic Response (CHR) or Partial Response (PR) at each scheduled timepoint (3, 6, 9, 12, 18 and 24 months), classified according to the ELN criteria and identification of baseline and on-treatment factors associated with (a) first attainment of CHR/PR and (b) maintenance (duration) of CHR/PR.

    Assessment timepoints: Baseline, 3, 6, 9, 12, 18 and 24 months (or last available follow-up).

    Summary metrics: Proportion (%) in CHR and PR at each timepoint

Secondary outcomes

  1. Time to Hematologic Response

    Time frame: Baseline to first documented CHR or PR (up to 24 months)

    Time (in months) from the first day of Ropeginterferon Alfa-2b treatment to achievement of CHR or PR hematologic response according to ELN criteria.

  2. Duration of Hematologic Response

    Time frame: From first CHR/PR to loss or last follow-up (up to 24 months)

    Interval between first documented CHR or PR and loss of that response, death, or last follow-up.

  3. Progression-Free Survival (PFS)

    Time frame: Baseline to event or last follow-up (up to 24 months)

    Time from treatment initiation to progression to post-PV myelofibrosis, acute myeloid leukemia, or death from any cause

  4. Thromboembolic Event Rate

    Time frame: Baseline to last follow-up (up to 24 months)

    Proportion of patients experiencing arterial or venous thrombotic or embolic events during treatment with Ropeginterferon.

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: Baseline to last follow-up (up to 24 months)

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) CTCAE v6.

  6. Treatment Discontinuation

    Time frame: Baseline to last follow-up (up to 24 months)

    Proportion of patients who discontinue Ropeginterferon for adverse events, lack of efficacy, or other clinical reasons.

  7. Dose Modifications and Adherence

    Time frame: Baseline to last follow-up (up to 24 months)

    Number and proportion of patients with significant dose changes (reductions or increases) and estimated adherence (planned vs observed dosing intervals).

  8. Normalization of Hematologic Parameters

    Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)

    Proportion of patients achieving target hematologic values: hematocrit <45%, leukocytes <10000/mm³, platelets <400000/mm³.

  9. JAK2 V617F Allele Burden

    Time frame: Baseline and at scheduled visits (3,6,9,12,18,24 months)

    Assessment of JAK2 V617F allele burden dynamics during Ropeginterferon treatment and correlation with hematologic response.

Study contacts

Contact information is provided by the study sponsor or research team.

Novella Pugliese, MD, PhD

CONTACT

[email protected]

+393396137232

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: MIRROR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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