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Sponsored by: |
Cooperative Study Group A for Hematology |
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Information provided by: | Cooperative Study Group A for Hematology |
ClinicalTrials.gov Identifier: | NCT00451594 |
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Thrombocytopenic Purpura |
Drug: Dexamethasone Drug: Prednisolone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura |
Estimated Enrollment: | 200 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2009 |
Glucocorticoid is the standard initial treatment of chronic ITP. But, There is no agreement on the appropriate dose and duration of treatment.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria :
Exclusion criteria :
Contact: Keun-Hee Kim, nurse | 82-2-3010-7290 | kuny9847@naver.com |
Korea, Republic of, Songpa-Gu | |
Asan Medical Center | Recruiting |
Seoul, Songpa-Gu, Korea, Republic of, 138-736 | |
Contact: Keun-Hee Kim, nurse 82-2-3010-7290 kuny9847@naver.com |
Principal Investigator: | Sung Hwa Bae, professor | Daegu Catholic Univertity Hospital, ROK |
Principal Investigator: | Jung-Hee Lee, professor | Asan Medical Center, ROK |
Study ID Numbers: | C-009 |
Study First Received: | March 22, 2007 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00451594 |
Health Authority: | Korea: Food and Drug Administration |
Dexamethasone Purpura Autoimmune Diseases Methylprednisolone Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Methylprednisolone acetate Prednisolone acetate Hemostatic Disorders |
Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopathy Thrombocytopenia Hemorrhagic Disorders Prednisolone Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic Dexamethasone acetate Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Skin Manifestations Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Protective Agents Neuroprotective Agents Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |