NCT07282132

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ropeginterferon alfa-2b (BESREMi®)	Ropeginterferon Alfa-2b was administered in accordance with the approved prescribing information.

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-03-26
• Completion: 2026-03-31
• First posted: 2025-12-15
• Last updated: 2025-12-15

Regulatory

• FDA-regulated drug study