Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06752941

LOW-PV Continuation

Led by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Updated on 2025-12-26

36

Participants Needed

13

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

LOW-PV Continuation

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until March 31, 2023
  • Patients who have signed the written informed consent for study participation
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 13 locations

1

Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia

Pavia, Lombardy, Italy, 27100

Not Yet Recruiting

2

Ospedale Borgo Roma, Divisione Ematologia

Verona, Veneto, Italy, 37134

Not Yet Recruiting

3

ASST Papa Giovanni XXIII, SC Ematologia

Bergamo, Italy

Actively Recruiting

4

Policlinico S. Orsola - Malpighi, UO Ematologia

Bologna, Italy

Actively Recruiting

5

Azienda Ospedaliero Universitaria Careggi, SOD Ematologia

Florence, Italy

Actively Recruiting

6

Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia

Milan, Italy

Actively Recruiting

7

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

Milan, Italy

Actively Recruiting

8

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

Naples, Italy, 80131

Actively Recruiting

9

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia

Novara, Italy, 28100

Actively Recruiting

10

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy, 00168

Not Yet Recruiting

11

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

Torino, Italy, 10126

Actively Recruiting

12

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

Varese, Italy

Actively Recruiting

13

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

Vicenza, Italy

Not Yet Recruiting

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Research Team

T

TIZIANO BARBUI, MD

CONTACT

F

FRANCESCA FENILI

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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LOW-PV Continuation | DecenTrialz