NCT00451594

High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Cooperative Study Group A for Hematology · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-03-23
• Last updated: 2011-01-13

Locations

1 site across 1 country: South Korea