Observing the effects of ropeginterferon alfa-2b in patients with Polycythemia Vera
Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
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 |
|---|---|
| Enrollment | 319 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 37 sites (Bergamo, Lombardia and 36 other locations) |
| Trial ID | NCT06506084 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Polycythemia Vera who require cytoreductive treatment.
Not a fit: Patients with contraindications for ropeginterferon alfa-2b will not benefit from this study.
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 performed: Other studies have shown promising results with similar treatments for Polycythemia Vera, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Bergamo, Lombardia and 36 other locations
- UOC Ematologia, ASST Papa Giovanni XXIII — Bergamo, Lombardia, Italy (Recruiting)
- Divisione Ematologia ASST, Grande Ospedale Metropolitano Niguarda — Milano, Lombardia, Italy (Recruiting)
- Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardia, Italy (Recruiting)
- U.O. Ematologia, Ospedale di Circolo e Fondazione Macchi Varese — Varese, Lombardia, 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)
- 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 — Firenze, 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 — Milano, Italy (Recruiting)
- Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo — Milano, 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 — Napoli, 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 — Gdańsk, Poland (Not_yet_recruiting)
- Pratia Onkologia, Department of Hematology and Cancer Prevention — Katowice, Poland (Not_yet_recruiting)
- Jagiellonian University Hospital, Department of Haematology — Krakow, Poland (Not_yet_recruiting)
- Copernicus Hospital — Lodz, Poland (Not_yet_recruiting)
- Medical University, Clinical Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation — Wrocław, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: Tiziano Barbui, Md
- Email: tbarbui@fondazionefrom.it
- Phone: +39 0352675134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.