Polycythemia VeraCONT-LOW-PVNCT06752941
LOW-PV Continuation
An observational study of Polycythemia Vera, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 13 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Polycythemia Vera
- How many people
- 36 participants
- Where
- 13 sitesItaly
- Study dates
- 30 Nov 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
ASST Papa Giovanni XXIII, SC Ematologia
Bergamo
Policlinico S. Orsola - Malpighi, UO Ematologia
Bologna
Azienda Ospedaliero Universitaria Careggi, SOD Ematologia
Florence
Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, SC Ematologia
Milan
Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
Milan
Azienda Ospedaliera Universitaria Federico II di Napoli Divisione di Ematologia e Trapianti del Midollo
Naples, 80131
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara SCDU Ematologia
Novara, 28100
Fondazione IRCCS Policlinico San Matteo, Divisione Ematologia
Pavia, Lombardy, 27100
Policlinico Universitario Fondazione Agostino Gemelli
Roma, 00168
A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
Torino, 10126
ASST Sette Laghi, Ospedale di Circolo e F. Macchi, Divisione UO Ematologia
Varese
Ospedale Borgo Roma, Divisione Ematologia
Verona, Veneto, 37134
Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia
Vicenza
About this study
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.
Read the 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
- Keywords
- Ropeginterferon alfa-2b
- Medical subject headings
- Polycythemia Vera
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Treatment response
Median HCT lower than 45% without disease progression
Measured: From date of randomization until the date of follow up assessed up to 6 months.
Secondary outcomes (7)
Complete hematological (CHR) and clinical remission (CR)
Rate of Efficacy
Measured: 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
Rate of Efficacy
Measured: From date of randomization until the date of follow up assessed up to 6 months
Frequency of phlebotomies
Rate of Efficacy
Measured: From date of randomization until the date of follow up assessed up to 6 months
Change in spleen size since treatment start
Rate of Efficacy
Measured: 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
Rate of Efficacy
Measured: During the follow up every 6months per patient.
Discontinuation of Ropeginterferon alfa-2b for any reason
Rate of Efficacy
Measured: 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
Rate of Safety
Measured: From date of randomization until the date of follow up assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start30 Nov 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TIZIANO BARBUI, MD, Study director, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752941
- Sponsor's protocol ID
- LOW-PV Continuation
- Acronym
- CONT-LOW-PV
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOW-PV Continuation
- ClinicalTrials.gov ID
- NCT06752941
- Acronym / sponsor ID
- CONT-LOW-PV / LOW-PV Continuation
- Conditions
- Polycythemia Vera
- Keywords
- Ropeginterferon alfa-2b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Complete hematological (CHR) and clinical remission (CR)
Time frame: 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
Frequency of phlebotomies
Time frame: 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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Polycythemia Vera
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
Recruiting
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
Myeloproliferative Neoplasm, Polycythemia Vera
RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV), Myelofibrosis (MF)
RecruitingPhase 3
INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Polycythemia Vera
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TIZIANO BARBUI, MD study director
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 13 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Treatment response (time frame: From date of randomization until the date of follow up assessed up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.