Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
NCT ID: NCT06506084
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
319 participants
OBSERVATIONAL
2022-09-08
2026-12-31
Brief Summary
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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.
Detailed Description
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Natural history of PV is marked by life threatening outcomes such as thrombosis, bleeding and clonal evolution towards myelofibrosis and acute myeloid leukemia. Treatment-relevant risk stratification is designed to estimate the likelihood of thrombotic complications, which is estimated to occur before or after diagnosis in 20-30% of patients according disease and patient-related risk factors. The cornerstone of treatment in PV includes scheduled phlebotomy, with a hematocrit (Hct) target of \<45% and low-dose aspirin in all patients, regardless of risk category. There is currently broad consensus regarding the need for cytoreductive drugs in high-risk patients with PV identified by age \>60 years and prior history of thrombosis.
The results of several andomized trials for the treatment of PV are now available, and, in addition to the standard drug hydroxyurea (HU), both a new ropegylated formulation of interferon alfa-2b3 and ruxolitinib4 are now available have been approved in Europe and US and European LeukemiaNet (ELN) investigators have recently provided recommendations for the use of these drugs in clinical practice in low-risk as well as high-risk patients.
After approval by EMA (2019) and FDA (2021), the drug (ROPEGINTERFERON ALFA-2B) was very recently approved and reimbursed by AIFA (2022) in some subgroups of patients with PV. 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, according to Determinazione AIFA 20 marzo 2008 about observational clinical studies, and Decreto Ministeriale 17 dicembre 2004 on non-profit studies.
It is not entirely known which is the percentage of patients who, after careful screening as required in good clinical practice, will fail the indications for concomitant clinical or laboratory abnormalities. Furthermore, the proportion of patients who discontinue the drug during follow-up for intolerance or other reasons is currently unknown and data on the benefit-risk ratio are limited.
Moreover, it should be noted that the haematological and clinical responses obtained in clinical trials not always are replicated in the studies of the real-world clinical practice. In fact, daily management of PV patients does not require the same stringent enrollment and follow-up criteria as instead are necessary in clinical trials. Our proposal may also contribute to better implement the results following the recent guidelines, particularly in some subgroups of patients in which AIFA has established the use with reimbursement by Italian National Health System (NHS) (i.e., patients intolerant to HU, women of childbearing age who plan pregnancy and patients with history of skin cancer).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
OTHER
Responsible Party
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Principal Investigators
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TIZIANO BARBUI, MD
Role: STUDY_DIRECTOR
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Locations
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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
Padua, 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
Napoli, , 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
Countries
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Other Identifiers
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ROPEG-PV
Identifier Type: -
Identifier Source: org_study_id