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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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

242

Start Date

2023-03-02

Completion Date

2027-08-31

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

OTHER

Hydroxyurea

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

OTHER

Ruxolitinib

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

Locations (35)

Novartis Investigative Site

Alessandria, AL, Italy

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Como, CO, Italy

Novartis Investigative Site

Cosenza, CS, Italy

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Lecce, LE, Italy

Novartis Investigative Site

Tricase, LE, Italy

Novartis Investigative Site

Monza, MB, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Piacenza, PC, Italy

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Parma, PR, Italy

Novartis Investigative Site

Reggio Calabria, RC, Italy

Novartis Investigative Site

Reggio Emilia, RE, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Pagani, SA, Italy

Novartis Investigative Site

Orbassano, TO, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Terni, TR, Italy

Novartis Investigative Site

Varese, VA, Italy

Novartis Investigative Site

Vicenza, VI, Italy

Novartis Investigative Site

Verona, VR, Italy

Novartis Investigative Site

Viterbo, VT, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Naples, Italy