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NCT05548062Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
242 (actual)
First submitted
16 Sept 2022
Start date
2 Mar 2023
Primary completion date
31 Aug 2027
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05548062

What you commit to

  • Study type: Observational
  • Participants enrolled: 242
  • From 2 Mar 2023 to the primary completion date, 31 Aug 2027
  • 30 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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AlessandriaItalyUnknown status
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AnconaItalyUnknown status
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BariItalyUnknown status
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BolognaItalyUnknown status
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CataniaItalyUnknown status
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ComoItalyUnknown status
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CosenzaItalyUnknown status
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FlorenceItalyUnknown status
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GenovaItalyUnknown status
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LecceItalyUnknown status
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MilanItalyUnknown status
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MonzaItalyUnknown status
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NaplesItalyUnknown status
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OrbassanoItalyUnknown status
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PadovaItalyUnknown status
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PaganiItalyUnknown status
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PalermoItalyUnknown status
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ParmaItalyUnknown status
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PiacenzaItalyUnknown status
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PisaItalyUnknown status
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Reggio CalabriaItalyUnknown status
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Reggio EmiliaItalyUnknown status
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RomaItalyUnknown status
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TerniItalyUnknown status
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TorinoItalyUnknown status
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TricaseItalyUnknown status
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VareseItalyUnknown status
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VeronaItalyUnknown status
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VicenzaItalyUnknown status
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ViterboItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.