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

NCT05548062

Active Not RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Polycythemia Vera

Interventions: Hydroxyurea, Ruxolitinib

Countries: Italy

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (33)

Alessandria, AL, Italy
Ancona, AN, Italy
Bari, BA, Italy
Bologna, BO, Italy
Como, CO, Italy
Cosenza, CS, Italy
Catania, CT, Italy
Florence, FI, Italy
Genova, GE, Italy
Lecce, LE, Italy
Tricase, LE, Italy
Monza, MB, Italy
Milan, MI, Italy
Palermo, PA, Italy
Palermo, PA, Italy
Piacenza, PC, Italy
Padova, PD, Italy
Pisa, PI, Italy
Parma, PR, Italy
Reggio Calabria, RC, Italy
Reggio Emilia, RE, Italy
Roma, RM, Italy
Roma, RM, Italy
Roma, RM, Italy
Pagani, SA, Italy
Orbassano, TO, Italy
Torino, TO, Italy
Terni, TR, Italy
Varese, VA, Italy
Vicenza, VI, Italy
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