Status:
COMPLETED
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00451594
Start Date
September 1 2005
End Date
December 1 2010
Last Update
January 13 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736