Observing the effects of ropeginterferon alfa-2b in patients with Polycythemia Vera
Official title: Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
Run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · NCT06506084 · Data updated 2026-11-12
This study is testing how well the drug ropeginterferon alfa-2b works and is tolerated by people with Polycythemia Vera who need treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 429 (estimated) |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 37 sites (Bergamo, Lombardy and 36 other locations) |
| Status | Recruiting |
| Started | September 8, 2022 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2029 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06506084 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older diagnosed with Polycythemia Vera who require cytoreductive treatment.
✕Probably not a fit
Patients with contraindications for ropeginterferon alfa-2b will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the use of ropeginterferon alfa-2b in patients diagnosed with Polycythemia Vera (PV). It will assess how well the drug can be prescribed and tolerated in real-world clinical settings, focusing on the risk-benefit profile of the treatment. The study will include patients who require cytoreductive treatment and will follow them over time to gather data on the drug's effectiveness and safety. The findings will help inform clinical practice for managing PV.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and quality of life for patients with Polycythemia Vera.
How similar studies have gone: Other studies have shown promising results with similar treatments for Polycythemia Vera, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: • Any contraindication for ropeginterferon alfa-2b according to the SmPC
Where it's running
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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
Show 31 more locations
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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 -
Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo Osseo
Catania, Italy Recruiting -
Azienda Ospedaliera S. Croce e Carle di Cuneo- Divisione di Ematologia,
Cuneo, Italy Recruiting -
Arcispedale Sant'Anna Azienda Ospedaliero - Universitaria di Ferrara, Unità Operativa di Ematologia
Ferrara, Italy Recruiting -
Azienda Ospedaliera Universitaria Careggi, Divisione di Ematologia
Florence, Italy Recruiting -
Azienda Ospedaliera Universitaria Policlinico "G. Martino", UOC Ematologia
Messina, Italy Recruiting -
Ospedale dell'Angelo, Dipartimento di Ematologia
Mestre, Italy Recruiting -
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia
Milan, Italy Recruiting -
Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
Milan, Italy Recruiting -
ASST MONZA Ospedale San Gerardo Clinica Ematologica
Monza, Italy Recruiting -
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, Italy Recruiting -
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, Italy Recruiting -
Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di Ematologia
Palermo, Italy Recruiting -
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy Recruiting -
Azienda Ospedaliera San Eugenio - UOC Ematologia
Roma, Italy Recruiting -
Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia
Roma, Italy Recruiting -
Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia
Roma, Italy Recruiting -
Ospedale Casa Sollievo della Sofferenza Istituto di Ricovero e Cura a Carattere Scientifico, U.O. Ematologia
San Giovanni Rotondo, Italy Recruiting -
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
Torino, Italy Recruiting -
Ospedale Maggiore, SC Ematologia
Trieste, Italy Recruiting -
Azienda Sanitaria Universitaria Integrata, Presidio Ospedaliero "Santa Maria della Misericordia", Clinica Ematologica
Udine, Italy Recruiting -
University Medical Center, Department of Hematology and Transplantation
Gdansk, Poland Recruiting -
Pratia Onkologia, Department of Hematology and Cancer Prevention
Katowice, Poland Recruiting -
Jagiellonian University Hospital, Department of Haematology
Krakow, Poland Recruiting -
Copernicus Hospital
Lodz, Poland Recruiting -
Medical University, Clinical Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw, Poland Recruiting
Study contacts
- Study coordinator: Tiziano Barbui, Md
- Email: tbarbui@fondazionefrom.it
- Phone: +39 0352675134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.