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Taking people in ItalyNo phase

Observational Study of Ropeginterferon Alfa-2b in Adults With Polycythemia Vera

Follows adults with polycythemia vera treated with ropeginterferon alfa-2b in routine clinical care.

Plain-language title generated from the registry record
Registry title: Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Key facts

Where
Alessandria, Bari, Bergamo, Bologna, Brescia, Cagliari, Catania, Cuneo, Ferrara, Florence, Messina, Mestre, Milan, Monza, Naples, Novara, Padova, Palermo, Pavia, Pisa, Roma, San Giovanni Rotondo, Torino, Trieste, Udine, Varese, Verona, and Vicenza, ItalySee the 32 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Source: NCT06506084, who can take part

Where in Italy

  • A.S.O. SS. Antonio e Biagio e C.Arrigo di AlessandriaAlessandria, ItalyTaking people
  • Azienda Ospedaliera Universitaria Consorziale - Policlinico, U.O. Ematologia con TrapiantoBari, ItalyTaking people
  • SC Ematologia, ASST Papa Giovanni XXIIIBergamo, ItalyTaking people
  • Policlinico S. Orsola - Malpighi, Unità di EmatologiaBologna, ItalyTaking people
  • ASST Spedali CiviliBrescia, ItalyTaking people
  • Ospedale Businco, S.C. Ematologia e CTMOCagliari, ItalyTaking people
  • Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo OsseoCatania, ItalyTaking people
  • Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,Cuneo, ItalyTaking people
  • Arcispedale Sant'Anna Azienda Ospedaliero - Universitaria di Ferrara, Unità Operativa di EmatologiaFerrara, ItalyTaking people
  • Azienda Ospedaliera Universitaria Careggi, Divisione di EmatologiaFlorence, ItalyTaking people
  • Azienda Ospedaliera Universitaria Policlinico "G. Martino", UOC EmatologiaMessina, ItalyTaking people
  • Ospedale dell'Angelo, Dipartimento di EmatologiaMestre, ItalyTaking people
  • Divisione Ematologia ASST, Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, EmatologiaMilan, ItalyTaking people
  • Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo OsseoMilan, ItalyTaking people
  • ASST MONZA Ospedale San Gerardo Clinica EmatologicaMonza, ItalyTaking people
  • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del MidolloNaples, ItalyTaking people
  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU EmatologiaNovara, ItalyTaking people
  • Clinica Medica I Azienda Ospedaliera di PadovaPadova, ItalyTaking people
  • Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di EmatologiaPalermo, ItalyTaking people
  • Divisione Ematologia, Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
  • Azienda Ospedaliera Universitaria PisanaPisa, ItalyTaking people
  • Azienda Ospedaliera San Eugenio - UOC EmatologiaRoma, ItalyTaking people
  • Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC EmatologiaRoma, ItalyTaking people
  • Policlinico Umberto I, Dipartimento Ematologia, Oncologia e DermatologiaRoma, ItalyTaking people
  • Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico, U.O. EmatologiaSan Giovanni Rotondo, ItalyTaking people
  • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia UTorino, ItalyTaking people
  • Ospedale Maggiore, SC EmatologiaTrieste, ItalyTaking people
  • Azienda Sanitaria Universitaria Integrata, Presidio Ospedaliero "Santa Maria della Misericordia", Clinica EmatologicaUdine, ItalyTaking people
  • U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi VareseVarese, ItalyTaking people
  • Divisione Ematologia, Ospedale Borgo RomaVerona, ItalyTaking people
  • Divisione Ematologia, Ospedale San BortoloVicenza, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Trial code
NCT06506084
Record updated
9 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Any contraindication for ropeginterferon alfa-2b according to the SmPC.

ClinicalTrials.gov NCT06506084