High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

Phase 3

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura

• Registration Number: NCT00451594
• Lead Sponsor: Cooperative Study Group A for Hematology

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).

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-03-22
• Study First Submitted QC: 2007-03-22
• Study First Posted: 2007-03-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-12
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
response rate and platelet count	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of