Study Design

  • Multicenter, randomized, controlled, open-label clinical trial
  • n = 195
    • High-dose dexamethasone: 95
    • Prednisone: 97
  • Setting: Nine study sites in China
  • Enrollment period: January 2011 and May 2014
  • Follow-up period: 6 months
  • Analysis: Intention-to-treat
  • Primary efficacy outcomes: Overall response (OR) and sustained response (SR) rates
    • OR = complete response (CR) + response
    • CR: Platelet count > 100,000 and absence of bleeding
    • Response: Platelet count > 30,000 and at least a two-fold increase from baseline and absence of bleeding
    • SR: Platelet count maintained > 30,000 with absence of bleeding symptoms and no requirement for additional ITP treatment for 6 months following achievement of initial response
  • Primary safety outcome: Adverse events
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