Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Prednisone

Criteria

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 diabetes

• 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.