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Active Not Recruiting NCT05548062

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

Conditions: Polycythemia Vera

Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 242
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Alessandria AL

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.

Eligibility Criteria

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Age ≥18 years. 3. Diagnosis of PV according to WHO 2008 or WHO 2016 and high-risk stratification according to European LeukemiaNet (ELN) classification. 4. At least one TE after diagnosis or up to 2 years prior to diagnosis. 5. 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05548062). StuddyBuddy aggregates publicly available trial information.