An observational study in Polycythemia Vera, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 33 sites in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
229 studies on the registry are indexed under Polycythemia Vera; 54 are open to participants now.
This study's enrollment of 242 is close to the median of 242 across 43 observational studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will involve patients in Italy with high-risk Polycythemia Vera
Inclusion Criteria:
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.
Other: Hydroxyurea
Patients on treatment with ruxolitinib who started treatment up to 18 months prior to enrollment.
Other: Ruxolitinib
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.
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.
Time frame: Up to 36 months
Blood pressure
Blood pressure is going to be collected
Time frame: 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
Time frame: Up to month 36
Number of patients with abnormal weight
Number of patients with abnormal weight will be collected
Time frame: Up to month 36
Number of patients with abnormal Neutrophil (NEP) count
Number of patients with abnormal Neutrophil (NEP) count will be collected
Time frame: 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
Time frame: Up to 36 months
Number of patients with abnormal Lymphocytes (LYP) count
Number of patients with abnormal Lymphocytes (LYP) count will be collected
Time frame: 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
Time frame: Up to 36 months
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
Time frame: Up to 36 months
Yearly incidence of TEs
Yearly incidence of Thromboembolic Events (TEs) will be collected
Time frame: 36 months
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
Time frame: 36 months
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.
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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