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
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | Songpa-gu |
Lead Sponsor | Collaborator |
---|---|
Cooperative Study Group A for Hematology |
Korea, Republic of,
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 |
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