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

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
View:

• 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.

Locations
Other Locations
Italy
A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria
RECRUITING
Alessandria
Azienda Ospedaliera Universitaria Consorziale - Policlinico, U.O. Ematologia con Trapianto
RECRUITING
Bari
UOC Ematologia, ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Policlinico S. Orsola - Malpighi, Unità di Ematologia
RECRUITING
Bologna
ASST-Spedali Civili
RECRUITING
Brescia
Ospedale Businco, S.C. Ematologia e CTMO
RECRUITING
Cagliari
Azienda Ospedaliero - Universitaria Policlinico Vittorio Emanuele - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo Osseo
RECRUITING
Catania
Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
RECRUITING
Cuneo
Arcispedale Sant'Anna Azienda Ospedaliero - Universitaria di Ferrara, Unità Operativa di Ematologia
RECRUITING
Ferrara
Azienda Ospedaliera Universitaria Careggi, Divisione di Ematologia
RECRUITING
Florence
Azienda Ospedaliera Universitaria Policlinico G. Martino, UOC Ematologia
RECRUITING
Messina
Ospedale dell'Angelo, Dipartimento di Ematologia
RECRUITING
Mestre
Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia
RECRUITING
Milan
Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
RECRUITING
Milan
ASST MONZA Ospedale San Gerardo Clinica Ematologica
RECRUITING
Monza
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
RECRUITING
Napoli
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
RECRUITING
Novara
Clinica Medica I Azienda Ospedaliera di Padova
RECRUITING
Padua
Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Divisione di Ematologia
RECRUITING
Palermo
Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Azienda Ospedaliera Universitaria Pisana
RECRUITING
Pisa
Azienda Ospedaliera San Eugenio - UOC Ematologia
RECRUITING
Roma
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia
RECRUITING
Roma
Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia
RECRUITING
Roma
Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico, U.O. Ematologia
RECRUITING
San Giovanni Rotondo
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
RECRUITING
Torino
Ospedale Maggiore, SC Ematologia
RECRUITING
Trieste
Azienda Sanitaria Universitaria Integrata, Presidio Ospedaliero Santa Maria della Misericordia, Clinica Ematologica
RECRUITING
Udine
U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese
RECRUITING
Varese
Divisione Ematologia, Ospedale Borgo Roma
RECRUITING
Verona
Divisione Ematologia, Ospedale San Bortolo
RECRUITING
Vicenza
Poland
University Medical Center, Department of Hematology and Transplantation
NOT_YET_RECRUITING
Gdansk
Pratia Onkologia, Department of Hematology and Cancer Prevention
NOT_YET_RECRUITING
Katowice
Jagiellonian University Hospital, Department of Haematology
NOT_YET_RECRUITING
Krakow
Copernicus Hospital
NOT_YET_RECRUITING
Lodz
Medical University, Clinical Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation
NOT_YET_RECRUITING
Wroclaw
Contact Information
Primary
TIZIANO BARBUI, MD
tbarbui@fondazionefrom.it
+39 0352675134
Backup
FENILI
sperimentazioni@fondazionefrom.it
Time Frame
Start Date: 2022-09-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 319
Related Therapeutic Areas
Sponsors
Leads: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

This content was sourced from clinicaltrials.gov