A large-scale trial testing the intensity of CYTOreductive therapy to prevent cardiovascular events In patients with Polycythemia Vera (PV)

Phase 3

Recruiting

• Conditions: polycythemia vera; To assess the benefit/risk profile of cytoreductive therapy with phlebotomy and/or hydroxyurea (HU) aimed at maintaining hematocrit (HCT) < 45% Vs. maintaining HCT in the range of 45-50% in patients with PV treated at the best of recommended therapies (e.g., low dose of aspirin when indicated and adequated control of standard cardiovascular risk factors); Blood - Haematological diseases

• Registration Number: ACTRN12609000046202
• Lead Sponsor: Consorzio Mario Negri Sud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Age > 18 years
Diagnosis of PV according to World Health Organisation (WHO) criteria
Ability and willingness to comply with all study requirements
Written and signed informed consent

Exclusion Criteria

Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
Known hypersensitivity or contraindication to study treatments
Significant liver (aspartate amino transferasi (AST) or alanine aminotransferasi (ALT) > 2.5 times upper limit normal (ULN)) or renal disease (creatinine > 2 mg/ml)
Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
History of active substance or alcohol abuse within the last year
Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol - Baseline and follow-up (F-UP) visits schedule and assessments

Study & Design

• Study Type: Interventional
• Study Design: Not specified