High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

This study is currently recruiting participants.

Verified by Cooperative Study Group A for Hematology, March 2007

Sponsored by:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT00451594

Purpose

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

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate

U.S. FDA Resources

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

Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:

platelet response rate at 6 months

Estimated Enrollment:	200
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009

Detailed Description:

Glucocorticoid is the standard initial treatment of chronic ITP. But, There is no agreement on the appropriate dose and duration of treatment.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria :

Patients with newly diagnosed ITP.
Age over 16 years
A platelet count of less than 30x109/L

Exclusion criteria :

Patients have a cause of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE
Patients have life threatening bleeding needed to use of IVIG
Patients have known contraindications to corticosteroid
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451594

Contacts

Contact: Keun-Hee Kim, nurse

82-2-3010-7290

kuny9847@naver.com

Locations

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

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:	Sung Hwa Bae, professor	Daegu Catholic Univertity Hospital, ROK
Principal Investigator:	Jung-Hee Lee, professor	Asan Medical Center, ROK

More Information

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 14, 2009