Polycytemia vera MedDRA version: 9.1 Level: LLT Classification code 10028576 Term: Myeloproliferative disorder
Conditions
Interventions
Trade Name: ONCOCARBIDE*20CPS 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxycarbamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Sponsors
G.I.M.E.M.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age ³ 18 years Diagnosis of PV according to WHO criteria Ability and willingness to comply with all study requirements Written and signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (AST or ALT > 2.5 times 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). No specific drug is recommended by the protocol for the two study arms: the choice to use phlebotomy and/or any cytoreductive drug is left to the Investigator.;Secondary Objective: Assessment of the full benefit/risk profile of experimental treatments in terms of efficacy and safety endpoints;Primary end point(s): To demonstrate that maintaining HCT < 45% (either with phlebotomy or HU) (standard cytoreduction) is more effective than maintaining HCT in the range of 45-50% (either with phlebotomy or HU) (experimental cytoreduction) in the reduction of CV deaths plus thrombotic events (stroke, acute coronary syndrome [ACS], transient ischemic attack [TIA], pulmonary embolism [PE], splanchnic thrombosis, deep vein thrombosis [DVT], and any other clinically relevant thrombotic event) 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). | — |
Countries
Italy
Outcome results
None listed