Active — Not RecruitingNot Applicable

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

Italy242 participantsStarted 2023-03-02

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Percentage of abnormalities presented in patients with Thromboembolic Events (TEs) during the follow up

Timeframe: Up to 36 months

Blood pressure

Timeframe: Up to month 36

Number of patients with abnormal Body Mass Index (BMI)

Timeframe: Up to month 36

Number of patients with abnormal weight

Timeframe: Up to month 36

Number of patients with abnormal Neutrophil (NEP) count

Timeframe: Up to 36 months

Number of patients with abnormal White blood Count (WBC)

Timeframe: Up to 36 months

Number of patients with abnormal Lymphocytes (LYP) count

Timeframe: Up to 36 months

Number of participants using antiplatelets and/or anticoagulants on the incidence of TEs

Timeframe: Up to 36 months

Trial details

NCT IDNCT05548062

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Polycythemia Vera trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Percentage of abnormalities presented in patients with Thromboembolic Events (TEs) during the follow up

Timeframe: Up to 36 months

Blood pressure

Timeframe: Up to month 36

Number of patients with abnormal Body Mass Index (BMI)

Timeframe: Up to month 36

Number of patients with abnormal weight

Timeframe: Up to month 36

Number of patients with abnormal Neutrophil (NEP) count

Timeframe: Up to 36 months

Number of patients with abnormal White blood Count (WBC)

Timeframe: Up to 36 months

Number of patients with abnormal Lymphocytes (LYP) count

Timeframe: Up to 36 months

Number of participants using antiplatelets and/or anticoagulants on the incidence of TEs

Timeframe: Up to 36 months