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

Sponsor
Federico II University
Study ID
NCT07282132
Status
Not Yet Recruiting

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Conditions

  • Polycytemia Vera

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 10, 2026
Status verified
Dec 2025
Primary completion
Mar 26, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

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 ]

Central Contacts