High-dose Dexamethasone Therapy as the Initial Treatment for Idiopathic Thrombocytopenic Purpura: Protocol for a Multicenter, Open-label, Single Arm Trial

Acta Med Okayama. 2018 Apr;72(2):197-201. doi: 10.18926/AMO/55863.

Abstract

Standard therapy for idiopathic thrombocytopenic purpura (ITP) has not been established. We are conducting a multicenter, prospective trial to determine the efficacy and safety of short-term, high-dose dexamethasone therapy in ITP patients aged 18-80 years with platelet counts of <20, 000 /μL, or with <50, 000/ μL and bleeding symptoms. The primary endpoints of this trial are the proportion of responses (complete plus partial response) on day 180 (day 46+180) after the completion of the 46-day high-dose dexamethasone therapy. The results of this investigation of the effectiveness and safety of this regimen will be essential for the establishment of standard therapy for ITP.

Keywords: high-dose dexamethasone therapy; idiopathic thrombocytopenic purpura; open-label; short-term; single-arm trial.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / therapeutic use
  • Antiviral Agents / therapeutic use
  • Dexamethasone / administration & dosage
  • Dexamethasone / therapeutic use*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / therapeutic use*
  • Helicobacter Infections / complications
  • Helicobacter Infections / drug therapy
  • Helicobacter pylori / isolation & purification
  • Hepatitis B / complications
  • Hepatitis B / drug therapy
  • Histamine H2 Antagonists / therapeutic use
  • Humans
  • Middle Aged
  • Proton Pump Inhibitors / therapeutic use
  • Purpura, Thrombocytopenic, Idiopathic / drug therapy*
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Antiviral Agents
  • Glucocorticoids
  • Histamine H2 Antagonists
  • Proton Pump Inhibitors
  • Dexamethasone