MYELOPROLIFERATIVE SYNDROMES MedDRA version: 9.1 Level: LLT Classification code 10015493 MedDRA version: 9.1 Level: PT Classification code 10036057
Conditions
Interventions
Trade Name: ONCOCARBIDE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Hydroxycarbamide
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 30-
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In this study are recruited patients suffering from chronic myeloproliferative syndromes who need pharmacological treatment with hydroxyurea to reduce the haematic red blood cell, white blood cell and platelet count. The experimental design of this research doesn?t take into account the use of drugs other than those that would have been administered to the patient outside from the study. Two groups of patients will be recruited in this study: a) patients eligible for hydroxyurea treatment who have never taken the medication before. b) Patients already in hydroxyurea treatment who have interrupted the administration of the drug for seven days. This period of interruption doesn?t determine any significant risk for the patient?s health. 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: informed consent denied
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study focuses the attention on the understanding of the mechanisms of action of hydroxyurea in the decrease of thrombotic vascular events, that aren?t in our opinion, explained by the only cytoreductive effect of the drug, but are probably also due to its capacity to reduce leucocyte activation. The main goal is the evaluation of the effect of hydroxyurea in the production of nitric oxide and cGMP in patients who suffer from chronic myeloproliferative syndromes after the administration of a load dose of hydroxyurea and in the steady-state. We will moreover evaluate the correlation of those events with the modification of the expression levels of tissue factor, plasmatic myeloperoxidase and leukocyte-platelet aggregates that are present in the blood as phenomena of leukocyte activation and of urinary levels of F2-Isoprostane as a biomarker of oxidative stress.;Secondary Objective: Secondary goals of this study are genotypic analysis for the variation of JAK2V617F allelic burden and its correlation with leukocyte activation levels. The modification in the activation state and in the localization of the transcription factor NF-kB will also be evaluated.;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed