LOW-PV continuation: follow-up of ropeginterferon alfa-2b in polycythemia vera responders
LOW-PV Continuation
This follow-up will track people with polycythemia vera who responded to ropeginterferon alfa-2b to see how well their response and side effect profile hold up over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 13 sites (Pavia, Lombardy and 12 other locations) |
| Trial ID | NCT06752941 on ClinicalTrials.gov |
What this trial studies
This is a multicenter longitudinal observational follow-up of 36 Italian patients who completed the LOW-PV randomized trial and were responders to ropeginterferon alfa-2b at study end (31-03-2023). Clinical data will be collected retrospectively every six months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026. Patients are followed at their respective participating hematology centers in Italy and no new investigational interventions are administered as part of the protocol. Given the descriptive design, no formal statistical hypothesis testing is planned and the focus is on long-term treatment durability and safety signals.
Who should consider this trial
Good fit: Ideal candidates are patients who were enrolled in the LOW-PV randomized trial, remained responders to ropeginterferon alfa-2b at the trial end (March 31, 2023), and who provide written informed consent for follow-up data collection.
Not a fit: Patients who did not receive ropeginterferon alfa-2b, who discontinued it before March 31, 2023, or who were non-responders in the original LOW-PV trial are unlikely to benefit from this continuation follow-up.
Why it matters
Potential benefit: If successful, this follow-up could provide clearer information about the durability of hematologic response and long-term safety of ropeginterferon alfa-2b, helping patients and clinicians make better treatment decisions.
How similar studies have performed: Previous randomized and extension studies of ropeginterferon alfa-2b (e.g., PROUD-PV/CONTINUATION-PV programs) have shown durable responses and an acceptable safety profile, but additional real-world long-term follow-up data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31, 2023. These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study. * Patients who have signed the written informed consent for study participation. Exclusion Criteria: * None
Where this trial is running
Pavia, Lombardy and 12 other locations
- Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia — Pavia, Lombardy, Italy (Not_yet_recruiting)
- Ospedale Borgo Roma, Divisione Ematologia — Verona, Veneto, Italy (Not_yet_recruiting)
- ASST Papa Giovanni XXIII, SC Ematologia — Bergamo, Italy (Recruiting)
- Policlinico S. Orsola - Malpighi, UO Ematologia — Bologna, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Careggi, SOD Ematologia — Florence, Italy (Recruiting)
- Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia — Milan, Italy (Recruiting)
- Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo — Milan, 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)
- Policlinico Universitario Fondazione Agostino Gemelli — Roma, Italy (Not_yet_recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U — Torino, Italy (Recruiting)
- ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia — Varese, Italy (Recruiting)
- Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia — Vicenza, Italy (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.