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Polycythemia VeraProsperoNCT05548062

Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 33 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Polycythemia Vera
What is being tested?
Hydroxyurea and Ruxolitinib
How many people
242 participants
Where
33 sitesItaly
Study dates
2 Mar 2023to 31 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will involve patients in Italy with high-risk Polycythemia Vera

Who may be able to join

  • Signed informed consent must be obtained prior to participation in the study.
  • Age ≥18 years.
  • Diagnosis of PV according to WHO 2008 or WHO 2016 and high-risk stratification according to European LeukemiaNet (ELN) classification.
  • At least one TE after diagnosis or up to 2 years prior to diagnosis.
  • Patients on treatment with hydroxyurea at enrollment and for at least 18 months prior to enrollment or those on treatment with ruxolitinib who started treatment up to 18 months before enrollment.

Who cannot join

None listed.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Italy33 sites

  • Novartis Investigative Site

    Alessandria, AL, 15121

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Catania, CT, 95123

  • Novartis Investigative Site

    Como, CO, 22100

  • Novartis Investigative Site

    Cosenza, CS, 87100

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Pagani, SA, 84016

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Parma, PR, 43126

  • Novartis Investigative Site

    Piacenza, PC, 29121

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Tricase, LE, 73039

  • Novartis Investigative Site

    Varese, VA, 21100

  • Novartis Investigative Site

    Verona, VR, 37134

  • Novartis Investigative Site

    Vicenza, VI, 36100

  • Novartis Investigative Site

    Viterbo, VT, 01033

Other trials in Italy

About this study

Official title: Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera

This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis.

This is a non-randomized study, and to ensure a sufficient number of patients in both cohorts, enrollment in each cohort will be terminated once the target of 150 patients has been reached.

Read the detailed description

All patients are already on treatment with hydroxyurea or ruxolitinib at enrollment as per clinical practice and independently of their participation in this study. In addition, the follow-up visits and the evaluation procedures required in the study protocol correspond to current clinical practice. According to local regulations related to observational studies, assessments such as blood tests are justified by the purpose and rationale of the study (i.e., the identification of possible predictive factors of TEs) and are considered current clinical practice. Data related to other procedures will be collected only if such procedures are performed as per clinical practice but are not required otherwise.

Patients in both cohorts will be followed for 3 years after enrollment and will have visits at Months 6, 12, 18, 24, 30 and 36. A time window of ± 1 month is permitted for all visits.

Being tested
Hydroxyurea, Ruxolitinib
Keywords
polycythemia vera, high-risk polycythemia vera, PV, Ruxolitinib, NIS, Italy, TE, predictive factors, hydroxyurea
Medical subject headings
Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxyureaOther

    Prospective observational study. There is no treatment allocation. Patients prescribed with Hydroxyurea are eligible to enroll into this study.

  • RuxolitinibOther

    Prospective observational study. There is no treatment allocation. Patients prescribed with Ruxolitinib are eligible to enroll into this study.

Study groups in NCT05548062
Study groupRoleWhat they receive
HydroxyureaPatients being treated with hydroxyurea at enrollment and for at least 18 months prior to enrollment. Patients may switch to ruxolitinib treatment during the study in case of inadequate response or intolerance.
Receives: Other: Hydroxyurea
RuxolitinibPatients on treatment with ruxolitinib who started treatment up to 18 months prior to enrollment.
Receives: Other: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of abnormalities presented in patients with Thromboembolic Events (TEs) during the follow up

    Demographics, blood pressure, laboratory blood tests, and use of antiplatelets and/or anticoagulants are predictors of TE occurrence, a univariate Cox regression model for repeated events will be applied for each predictor considering all the TEs occurring within 12 months and the time from baseline to each occurrence. Predictors found statistically significant at the 5% level will then be considered in a multivariate Cox regression model for repeated events.

    Measured: Up to 36 months

  2. Blood pressure

    Blood pressure is going to be collected

    Measured: Up to month 36

  3. Number of patients with abnormal Body Mass Index (BMI)

    Number of patients with abnormal Body Mass Index (BMI) will be collected

    Measured: Up to month 36

  4. Number of patients with abnormal weight

    Number of patients with abnormal weight will be collected

    Measured: Up to month 36

  5. Number of patients with abnormal Neutrophil (NEP) count

    Number of patients with abnormal Neutrophil (NEP) count will be collected

    Measured: Up to 36 months

  6. Number of patients with abnormal White blood Count (WBC)

    Number of patients with abnormal White blood Count (WBC) will be collected

    Measured: Up to 36 months

  7. Number of patients with abnormal Lymphocytes (LYP) count

    Number of patients with abnormal Lymphocytes (LYP) count will be collected

    Measured: Up to 36 months

  8. Number of participants using antiplatelets and/or anticoagulants on the incidence of TEs

    Number of participants using antiplatelets and/or anticoagulants on the incidence of Thromboembolic Events (TEs) will be collected

    Measured: Up to 36 months

Secondary outcomes (4)

  1. Synergistic combinations of predictive factors

    Synergistic combinations of predictive factors (Red cell Distribution Width, neutrophils, lymphocytes, neutrophil/ lymphocyte ratio and platelets).

    Synergy score is defined as the product of the individual significances of variable 1 and 2 (expected) divided by the significance of the two-variable model (observed) To investigate cases of extreme synergy, instances in which two variables split the given cohort into high-risk and low-risk patients are far better than either variable alone. A simple synergy scoring metric to rank variable in terms of synergy (S):S12=(P1*P2)/P12 where P1 and P2 are the maximum possible (Cox regression derived) p-values for variable 1 and variable 2 and P12 was the max. p-value possible from the combination of variables 1 and 1. This synergy is intended to capture a variable that may provide exclusive non-redundant information when attempting to split a cohort based on risk and may provide an added insight into the functional/clinical rationale of a model

    Measured: Up to 36 months

  2. Yearly incidence of TEs

    Yearly incidence of Thromboembolic Events (TEs) will be collected

    Measured: 36 months

  3. Incidence of arterial and venous TEs in the hydroxyurea and ruxolitinib cohorts

    Incidence of arterial and venous TEs in the hydroxyurea and ruxolitinib cohorts will be collected

    Measured: 36 months

  4. Incidence and severity of adverse events

    Incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start2 Mar 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Prospective
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05548062
Sponsor's protocol ID
CINC424BIT01
Acronym
Prospero
Status last verified
Sep 2026
First submitted
16 Sep 2022
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 33 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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of abnormalities presented in patients with Thromboembolic Events (TEs) during the follow up (time frame: Up to 36 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05548062.

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 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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