Condition: Polycythemia Vera · Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
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.
This description comes directly from the study's public registry record.
TIZIANO BARBUI, MD · +39 0352675134 · tbarbui@fondazionefrom.it
FENILI · sperimentazioni@fondazionefrom.it
Always discuss trial participation with your own doctor first.
| SC Ematologia, ASST Papa Giovanni XXIII | Bergamo, Lombardy, Italy | Recruiting |
| Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda | Milan, Lombardy, Italy | Recruiting |
| Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo | Pavia, Lombardy, Italy | Recruiting |
| U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese | Varese, Lombardy, Italy | Recruiting |
| Clinica Medica I Azienda Ospedaliera di Padova | Padova, Veneto, Italy | Recruiting |
| Divisione Ematologia, Ospedale Borgo Roma | Verona, Veneto, Italy | Recruiting |
| Divisione Ematologia, Ospedale San Bortolo | Vicenza, Veneto, Italy | Recruiting |
| A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria | Alessandria, Italy | Recruiting |
| Azienda Ospedaliera Universitaria Consorziale - Policlinico, U.O. Ematologia con Trapianto | Bari, Italy | Recruiting |
| Policlinico S. Orsola - Malpighi, Unità di Ematologia | Bologna, Italy | Recruiting |
| ASST-Spedali Civili | Brescia, Italy | Recruiting |
| Ospedale Businco, S.C. Ematologia e CTMO | Cagliari, Italy | Recruiting |
+ 25 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06506084