Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Study ID
NCT06506084
Status
Active Not Recruiting

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b — DRUG
    Data will be collected at each visit during the observational study (total duration: 24 months). In accordance with routine clinical practice in this patient population, visits are expected to take place every 6 months. Patients who discontinue ropeginterferon alfa-2b treatment at any time will no longer be followed up.

Study Details

Polycythaemia vera (PV) is associated with a reduced quality of life, a high rate of vascular events, and an intrinsic risk of disease evolution. The results of several randomised trials for the treatment with new cytoreductive agents are now available, among which a new ropegylated formulation of interferon alfa-2b (ropeginterferon alfa-2b) have been recently approved in Europe and USA \[EMA (2019), FDA (2021) and AIFA (2022)\]. The use of this drug in clinical practice is an opportunity for a prospective observational study in a rare disease such as PV; the aim is to evaluate its impact in the practical management of these patients. Therefore, the main objectives of the present study are to determine: (i) to what extent ropeginterferon alfa-2b can be prescribed and tolerated in patients with PV; (ii) the risk-benefit of ropeginterferon alfa-2b in patients with PV, followed-up in real-world clinical practice.

Key Dates

Start date
Sep 8, 2022
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
319 participants (estimated)

Primary Outcome Measure

Complete hematological remission (CHR)* after 1 and 2 years of treatment. [ Time Frame: At baseline and during the follow up at 6/12/18/24 months per patient. ]

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