Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点开始时间: 2008年4月11日最近更新: 2012年3月19日

试验速览

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•Signed written informed consent according to IGH/EU/GCP and national local laws Newly diagnosed untreated ITP adult patients Age > 18 < 80 years Platelet count <20x109/L Platelet count > 20 x109/L and <50x109/L plus bleeding with score > 8 (according to grading scale at paragraph 7.1) Baseline Quality of Life evaluation questionnaire filled in
•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

•Active malignancy at time of study entry Steroids administration (PDN <1mg/Kg/day) for more than 2 days before randomization Concomitant treatment with anti-platelet and or anti-coagulant drugs Concomitant severe psychiatric disorders Not confirmed diagnosis of ITP for o *Positivity of autoimmunity markers: antinucleus (1:80), anti-tireoglobulin, anti-tireoperoxidase, anti-cardiolipin (≥ 40 GPL UmL), anti-b2glycoprotein (≥ 40 IgG U/mL) antibodies, Lupus Anticoagulant (KCT ratio, dRVVT ratios 1.5 times the upper normal limit ), direct antiglobulin test (DAT ). o Presence of autoimmune hemolytic anemia o Presence of connective tissue disease Women who are pregnant or breastfeeding Hypertension, cardiovascular diseases and diabetes requiring treatment Liver and kidney function impairment (creatinine, ALT, AST >2 times upper normal limit) HCVAb, HIVAb, HBsAg, HBcAb seropositive status Chronic liver disease Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis Intake of drugs not previously taken within one week before diagnosis Bleeding score 15 due to ICH or to GI bleeding (according to grading scale at paragraph 7.1, Tab. 3) Active gastric ulcer

发起方

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO