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

NCT07282132 | Not Yet Recruiting FDA Drug

• 1 other identifier: AIFA-RSO-3948
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polycytemia Vera

Keywords

Ropeginterferon alpha 2b

Outcome Measures

Primary Outcomes (1)

• Longitudinal Analysis of Hematologic Response (CR/PR) to Ropeginterferon Alfa-2b in polycythemia vera

  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

  From enrollment to the end of treatment or at least 12 months of treatment

Secondary Outcomes (9)

• Time to Hematologic Response

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

• Duration of Hematologic Response

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

• Progression-Free Survival (PFS)

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

• Thromboembolic Event Rate

  Baseline to last follow-up (up to 24 months)

• Incidence of Treatment-Emergent Adverse Events

  Baseline to last follow-up (up to 24 months)

Study Arms (1)

Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b

Data will be collected retrospectively from patient medical records and will include: 1. Demographic Data 2. Clinical Characteristics of PV 3. Treatment Information. Details on Ropeginterferon Alfa-2b therapy: Dosage; Treatment schedule and duration; Clinical and hematologic response; Treatment discontinuation and reasons for interruption 4. Clinical and Hematologic Response: Hematologic parameters (hemoglobin, hematocrit, platelet count, etc.); Clinical status during treatment; Spleen size assessed via abdominal ultrasound (when available); Documentation of baseline values, prior therapies, dosing schedules, and response assessments at: 3, 6, 9, 12, 18, and 24 months; Discontinuation rates and reasons for stopping therapy 5. Molecular Response: Quantification of JAK2 V617F allele burden over time 6. Adverse Events: Any clinically relevant complications or side effects

Drug: Ropeginterferon alfa-2b (BESREMi®)

Interventions

Ropeginterferon alfa-2b (BESREMi®) DRUG

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

Patients with Polycythemia Vera Receiving Ropeginterferon aplha 2b

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients diagnosed with Polycythemia Vera (PV) according to current diagnostic criteria who have received at least one administration of Ropeginterferon Alfa-2b (BESREMI) as part of their disease management. Eligible patients must have complete clinical and laboratory information available and must be followed at one of the participating centers. All participants must provide written informed consent prior to inclusion in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Central Study Contacts

Novella Pugliese, MD, PhD

CONTACT

+393396137232; novypugliese@yahoo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 15, 2025
• Study Start: January 10, 2026
• Primary Completion: March 26, 2026
• Study Completion: March 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share