LOW-PV Continuation

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Polycythemia Vera

Keywords

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Ropeginterferon alfa-2b

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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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Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia

Pavia, Lombardy, Italy

Site Status

Ospedale Borgo Roma, Divisione Ematologia

Verona, Veneto, Italy

Site Status

ASST Papa Giovanni XXIII, SC Ematologia

Bergamo, , Italy

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Policlinico S. Orsola - Malpighi, UO Ematologia

Bologna, , Italy

Site Status

Azienda Ospedaliero Universitaria Careggi, SOD Ematologia

Florence, , Italy

Site Status

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia

Milan, , Italy

Site Status

Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo

Napoli, , Italy

Site Status

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, , Italy

Site Status

Policlinico Universitario Fondazione Agostino Gemelli

Roma, , Italy

Site Status

A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U

Torino, , Italy

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ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia

Varese, , Italy

Site Status

Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia

Vicenza, , Italy

Site Status

Countries

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Italy

Other Identifiers

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