LOW-PV Continuation (CONT-LOW-PV)

December 19, 2025 updated by: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Bergamo, Italy
        • Recruiting
        • ASST Papa Giovanni XXIII, SC Ematologia
        • Contact:
        • Sub-Investigator:
          • Marta Bellini, MD
        • Principal Investigator:
          • Alessandro Rambaldi, MD
        • Sub-Investigator:
          • Maria Chiara Finazzi, MD
        • Sub-Investigator:
          • Annalisa Condorelli, MD
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola - Malpighi, UO Ematologia
        • Contact:
        • Principal Investigator:
          • Michele Cavo, MD
        • Sub-Investigator:
          • Francesca Palandri, MD
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi, SOD Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro Maria Vannucchi, MD
        • Sub-Investigator:
          • Francesca Guglielmelli, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandra Iurlo, MD
      • Milan, Italy
        • Recruiting
        • Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
        • Contact:
        • Principal Investigator:
          • Francesca Lunghi, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
        • Principal Investigator:
          • Fabrizio Pane, MD
        • Contact:
        • Sub-Investigator:
          • Novella Pugliese, MD
        • Sub-Investigator:
          • GIada Miccioli Casadei, MD
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Andrea Patriarca, MD
      • Roma, Italy, 00168
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
        • Contact:
        • Principal Investigator:
          • Giulia Benevolo, MD
      • Varese, Italy
        • Recruiting
        • ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia
        • Principal Investigator:
          • Marco Brociner, MD
        • Contact:
      • Vicenza, Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia
        • Contact:
        • Principal Investigator:
          • ELisa Rumi, MD
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Not yet recruiting
        • Ospedale Borgo Roma, Divisione Ematologia
        • Principal Investigator:
          • Massimiliano Bonifacio, MD
        • Contact:
        • Sub-Investigator:
          • Luigi Scaffidi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Thirty-six patients completed the Low-PV RCT and were still under treatment with Ropeg at study end. The "LOW-PV Continuation" study aim to update data of all these patients, regardless of the treatment they are undergoing at the time of enrollment in the current study, after having obtained their informed consent to participation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maintenance of Treatment response
Time Frame: From date of randomization until the date of follow up assessed up to 6 months.
Median HCT lower than 45% without disease progression
From date of randomization until the date of follow up assessed up to 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete hematological (CHR) and clinical remission (CR)
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Change in JAK2 variant allele frequency (VAF) since treatment start
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Frequency of phlebotomies
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Change in spleen size since treatment start
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Incidence of any of the following: o arterial and venous thrombotic events; o hemorrhagic events; o disease related symptoms; o disease evolutions into myelofibrosis and acute leukemia; o secondary malignancies o death
Time Frame: During the follow up every 6months per patient.
Rate of Efficacy
During the follow up every 6months per patient.
Discontinuation of Ropeginterferon alfa-2b for any reason
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Efficacy
From date of randomization until the date of follow up assessed up to 6 months
Incidence and grading of any adverse event related to Ropeginterferon alfa-2b
Time Frame: From date of randomization until the date of follow up assessed up to 6 months
Rate of Safety
From date of randomization until the date of follow up assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: TIZIANO BARBUI, MD, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOW-PV Continuation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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