A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Sponsor
- Cooperative Study Group A for Hematology
- Enrollment
- 157
- Locations
- 1
- Primary Endpoint
- response rate and platelet count
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
Detailed Description
Patients will be randomized to one of two study arms: dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1). Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
response rate and platelet count
Time Frame: 6 years
Endpoint definitions and criteria for evaluation: This study is designed to compare the effectiveness of high dose dexamethasone with conventional dose prednisone for patient with ITP. The effectiveness will be evaluated in terms of response rate and platelet count at 6 months after the treatment