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

Recruitingn/aAges 18 Years - 100 YearsAllFROM- Fondazione per la Ricerca Ospedale di Berga…
NCT06506084 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients diagnosed with Polycythemia Vera by WHO 2016 * Patient aged ≥ 18 years old * Patients in need of cytoreductive treatments with ropeginterferon alfa-2b in first or later lines according to the reimbursability criteria defined by the Italian National Health System * Patients who have signed the written informed consent for study participation. Exclusion Criteria: • Any contraindication for ropeginterferon alfa-2b according to the SmPC
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What it tests

  • Ropeginterferon alfa-2b
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Where

37 sites
SC Ematologia, ASST Papa Giovanni XXIII
Bergamo, Italy
Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda
Milan, Italy
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
Varese, Italy
Clinica Medica I Azienda Ospedaliera di Padova
Padova, Italy
Divisione Ematologia, Ospedale Borgo Roma
Verona, Italy
Divisione Ematologia, Ospedale San Bortolo
Vicenza, Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
Alessandria, Italy

…and 29 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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