NCT06752941

LOW-PV Continuation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial "LOW-PV." Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.

Detailed description

Multicentre longitudinal observational Italian study of patients with Polycythemia Vera (PV) enrolled in Low-PV RCT and still receiving the experimental drug (i.e., Ropeginterferon alfa-2b) at study end (31-03-2023). Thirty-six patients who completed the Low-PV RCT and were responders to Interferon, continued treatment with the drug and are followed at their respective centers in Italy. The "LOW-PV Continuation" study aims to collect after 1,2,3 years the data on these patients, regardless of the treatment they were undergoing at the time of enrollment in the current study, after their informed consent. In details, data will be collected retrospectively from March 31, 2023 to November 2024 and prospectively from December 1, 2024 to March 31, 2026. Given the descriptive nature of the study, no formal statistical hypothesis will be made.

Conditions

• Polycythemia Vera

Timeline

• Start date: 2024-11-30
• Primary completion: 2026-03-30
• Completion: 2026-03-31
• First posted: 2024-12-31
• Last updated: 2025-12-26

Locations

13 sites across 1 country: Italy