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High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

This study has been completed.
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00451594
First received: March 22, 2007
Last updated: January 12, 2011
Last verified: January 2011
History of Changes

March 22, 2007
January 12, 2011
September 2005
December 2010   (final data collection date for primary outcome measure)
response rate and platelet count [ Time Frame: 6 years ] [ Designated as safety issue: No ]
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
platelet response rate at 6 months
Complete list of historical versions of study NCT00451594 on ClinicalTrials.gov Archive Site
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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

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

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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Thrombocytopenic Purpura
  • 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.
    Other Name: Dexa
  • 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
    Other Name: PD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00451594
C-009
Yes
COSAH, Cooperative Study Group A for Hematology
Cooperative Study Group A for Hematology
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Principal Investigator: Sung Hwa Bae, professor Daegu Catholic Univertity Hospital, ROK
Principal Investigator: Jung-Hee Lee, professor Asan Medical Center, ROK
Cooperative Study Group A for Hematology
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP