Clinical Research Directory
Browse clinical research sites, groups, and studies.
Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Summary
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 Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
319
Start Date
2022-09-08
Completion Date
2026-12-31
Last Updated
2025-12-26
Healthy Volunteers
Not specified
Conditions
Interventions
Ropeginterferon alfa-2b
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.
Locations (37)
UOC Ematologia, ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
Varese, Lombardy, Italy
Clinica Medica I Azienda Ospedaliera di Padova
Padova, Veneto, Italy
Divisione Ematologia, Ospedale Borgo Roma
Verona, Veneto, Italy
Divisione Ematologia, Ospedale San Bortolo
Vicenza, Veneto, Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
Alessandria, Italy
Azienda Ospedaliera Universitaria Consorziale - Policlinico, U.O. Ematologia con Trapianto
Bari, Italy
Policlinico S. Orsola - Malpighi, Unità di Ematologia
Bologna, Italy
ASST-Spedali Civili
Brescia, Italy
Ospedale Businco, S.C. Ematologia e CTMO
Cagliari, Italy
Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo Osseo
Catania, Italy
Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
Cuneo, Italy
Arcispedale Sant'Anna Azienda Ospedaliero - Universitaria di Ferrara, Unità Operativa di Ematologia
Ferrara, Italy
Azienda Ospedaliera Universitaria Careggi, Divisione di Ematologia
Florence, Italy
Azienda Ospedaliera Universitaria Policlinico "G. Martino", UOC Ematologia
Messina, Italy
Ospedale dell'Angelo, Dipartimento di Ematologia
Mestre, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia
Milan, Italy
Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
Milan, Italy
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, Italy
Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di Ematologia
Palermo, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Azienda Ospedaliera San Eugenio - UOC Ematologia
Roma, Italy
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia
Roma, Italy
Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia
Roma, Italy
Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico, U.O. Ematologia
San Giovanni Rotondo, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
Torino, Italy
Ospedale Maggiore, SC Ematologia
Trieste, Italy
Azienda Sanitaria Universitaria Integrata, Presidio Ospedaliero "Santa Maria della Misericordia", Clinica Ematologica
Udine, Italy
University Medical Center, Department of Hematology and Transplantation
Gdansk, Poland
Pratia Onkologia, Department of Hematology and Cancer Prevention
Katowice, Poland
Jagiellonian University Hospital, Department of Haematology
Krakow, Poland
Copernicus Hospital
Lodz, Poland
Medical University, Clinical Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw, Poland