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High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

NCT00451594 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2011-01-13

No results posted yet for this study

Summary

To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

Dexamethasone

Pulse high dose dexamethasone (Arm 1) 1. Patients will receive 40 mg of oral dexamethasone daily for four consecutive days. 2. Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14 3. If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given. 4. If the platelet count drops below 30X109/L within the first 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering. 5. Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments.

DRUG

Prednisolone

Conventional dose prednisone (Arm 2) 1. Prednisone, 1 mg/kg is started at diagnosis. If the platelet count is more than 100X109/L, the dose should be used for 4 weeks minimally and then tapered by 10 mg/1 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/1 wk thereafter. (Ann Intern Med 1997, 126, 307-14). If the platelet count is between 30X109/L and 100X109/L, prednisone 1 mg/kg should be used for 8 weeks maximally and then tapered by 10 mg/2 wk until the dose reaches 0.5 mg/kg of body weight and by 5 mg/2 wk thereafter. 2. Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months

Sponsors & Collaborators

  • Cooperative Study Group A for Hematology

    lead NETWORK

Principal Investigators

  • Sung Hwa Bae, professor · Daegu Catholic Univertity Hospital, ROK

  • Jung-Hee Lee, professor · Asan Medical Center, ROK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00451594 on ClinicalTrials.gov