Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytope… (NCT00657410) | Clinical Trial Compass
CompletedPhase 3
Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura
Italy150 participantsStarted 2008-04
Plain-language summary
RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which drug is more effective in treating primary immune thrombocytopenic purpura.
PURPOSE: This randomized phase III trial is studying high-dose dexamethasone to see how well it works compared to standard-dose prednisone in treating patients with newly diagnosed, previously untreated primary immune thrombocytopenic purpura.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* 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 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
Exclusion criteria
* Active malignancy at time of study entry
* Steroids administration (PDN \<1mg/Kg/day) for more than 5 days before randomization
* Concomitant treatment with anti-platelet and or anti-coagulant drugs
* Concomitant severe psychiatric disorders
* Not confirmed diagnosis of ITP for
* \*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 ).
* Presence of autoimmune hemolytic anemia
* Presence of connective tissue disease
* Women who are pregnant or breastfeeding
* Cardiovascular diseases requiring treatment
* Severe non-controlled, despite therapy, hypertension and…
What they're measuring
1
Final response (complete, partial, and minimal response) rate from evaluation of initial response
Timeframe: At day +180 from evaluation of initial response
Trial details
NCT IDNCT00657410
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto