High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
NCT ID: NCT00451594
Last Updated: 2011-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
157 participants
INTERVENTIONAL
2005-09-30
2010-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
16 Years
ALL
No
Sponsors
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Cooperative Study Group A for Hematology
NETWORK
Responsible Party
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Cooperative Study Group A for Hematology
Principal Investigators
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Sung Hwa Bae, professor
Role: PRINCIPAL_INVESTIGATOR
Daegu Catholic Univertity Hospital, ROK
Jung-Hee Lee, professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, ROK
Locations
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Asan Medical Center
Seoul, Songpa-gu, South Korea
Countries
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Related Links
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A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURA
Other Identifiers
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C-009
Identifier Type: -
Identifier Source: org_study_id
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