High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451594
• Other study ID #: C-009
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2007
• Last updated: January 12, 2011
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Cooperative Study Group A for Hematology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria :

• a true thrombocytopenia on blood smear

• adequate megakaryopoiesis on bone marrow examination

• the absence of clinically apparent associated conditions or cause of thrombocytopenia

• Age over 16 years

• A platelet count of less than 30x109/L

Exclusion criteria :

• previous treatment for ITP.

• other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.

• Patients with life threatening bleeding and pregnant women should be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Dexamethasone
Pulse high dose dexamethasone (Arm 1) Patients will receive 40 mg of oral dexamethasone daily for four consecutive days. Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14 If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given. 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. Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments.
• Prednisolone
Conventional dose prednisone (Arm 2) 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. Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate and platelet count	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	6 years	No

External Links

•   A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURA