Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
Prospero
Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
1 other identifier
observational
242
1 country
35
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedStudy Start
First participant enrolled
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 3, 2025
September 1, 2025
4.5 years
September 16, 2022
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
Up to 36 months
Blood pressure
Blood pressure is going to be collected
Up to month 36
Number of patients with abnormal Body Mass Index (BMI)
Number of patients with abnormal Body Mass Index (BMI) will be collected
Up to month 36
Number of patients with abnormal weight
Number of patients with abnormal weight will be collected
Up to month 36
Number of patients with abnormal Neutrophil (NEP) count
Number of patients with abnormal Neutrophil (NEP) count will be collected
Up to 36 months
Number of patients with abnormal White blood Count (WBC)
Number of patients with abnormal White blood Count (WBC) will be collected
Up to 36 months
Number of patients with abnormal Lymphocytes (LYP) count
Number of patients with abnormal Lymphocytes (LYP) count will be collected
Up to 36 months
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
Up to 36 months
Secondary Outcomes (4)
Synergistic combinations of predictive factors
Up to 36 months
Yearly incidence of TEs
36 months
Incidence of arterial and venous TEs in the hydroxyurea and ruxolitinib cohorts
36 months
Incidence and severity of adverse events
36 months
Study Arms (2)
Hydroxyurea
Patients 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.
Ruxolitinib
Patients on treatment with ruxolitinib who started treatment up to 18 months prior to enrollment.
Interventions
Prospective observational study. There is no treatment allocation. Patients prescribed with Hydroxyurea are eligible to enroll into this study.
Prospective observational study. There is no treatment allocation. Patients prescribed with Ruxolitinib are eligible to enroll into this study.
Eligibility Criteria
The study will involve patients in Italy with high-risk Polycythemia Vera
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Novartis Investigative Site
Alessandria, AL, 15121, Italy
Novartis Investigative Site
Ancona, AN, 60126, Italy
Novartis Investigative Site
Bari, BA, 70124, Italy
Novartis Investigative Site
Bologna, BO, 40138, Italy
Novartis Investigative Site
Como, CO, 22100, Italy
Novartis Investigative Site
Cosenza, CS, 87100, Italy
Novartis Investigative Site
Catania, CT, 95123, Italy
Novartis Investigative Site
Florence, FI, 50134, Italy
Novartis Investigative Site
Genova, GE, 16132, Italy
Novartis Investigative Site
Lecce, LE, 73100, Italy
Novartis Investigative Site
Tricase, LE, 73039, Italy
Novartis Investigative Site
Monza, MB, 20900, Italy
Novartis Investigative Site
Milan, MI, 20122, Italy
Novartis Investigative Site
Palermo, PA, 90127, Italy
Novartis Investigative Site
Palermo, PA, 90146, Italy
Novartis Investigative Site
Piacenza, PC, 29100, Italy
Novartis Investigative Site
Padua, PD, 35100, Italy
Novartis Investigative Site
Padua, PD, 35128, Italy
Novartis Investigative Site
Pisa, PI, 56124, Italy
Novartis Investigative Site
Parma, PR, 43126, Italy
Novartis Investigative Site
Reggio Calabria, RC, 89100, Italy
Novartis Investigative Site
Reggio Emilia, RE, 42123, Italy
Novartis Investigative Site
Roma, RM, 00161, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Roma, RM, 00189, Italy
Novartis Investigative Site
Pagani, SA, 84016, Italy
Novartis Investigative Site
Orbassano, TO, 10043, Italy
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Terni, TR, 05100, Italy
Novartis Investigative Site
Varese, VA, 21100, Italy
Novartis Investigative Site
Vicenza, VI, 36100, Italy
Novartis Investigative Site
Verona, VR, 37134, Italy
Novartis Investigative Site
Viterbo, VT, 01033, Italy
Novartis Investigative Site
Napoli, 80131, Italy
Novartis Investigative Site
Napoli, 80132, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 21, 2022
Study Start
March 2, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share