Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
NCT ID: NCT05548062
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
242 participants
OBSERVATIONAL
2023-03-02
2027-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Hydroxyurea
Prospective observational study. There is no treatment allocation. Patients prescribed with Hydroxyurea are eligible to enroll into this study.
Ruxolitinib
Patients on treatment with ruxolitinib who started treatment up to 18 months prior to enrollment.
Ruxolitinib
Prospective observational study. There is no treatment allocation. Patients prescribed with Ruxolitinib are eligible to enroll into this study.
Interventions
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Hydroxyurea
Prospective observational study. There is no treatment allocation. Patients prescribed with Hydroxyurea are eligible to enroll into this study.
Ruxolitinib
Prospective observational study. There is no treatment allocation. Patients prescribed with Ruxolitinib are eligible to enroll into this study.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Padua, PD, Italy
Novartis Investigative Site
Padua, 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
Napoli, , Italy
Novartis Investigative Site
Napoli, , Italy
Countries
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Other Identifiers
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CINC424BIT01
Identifier Type: -
Identifier Source: org_study_id
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