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High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

This study has been completed.
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT00451594
First received: March 22, 2007
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • response rate and platelet count [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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


Enrollment: 157
Study Start Date: September 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
    Other Name: Dexa
    Drug: 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 Name: PD
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 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).

  Eligibility

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

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

Locations
Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
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

Additional Information:
A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT00451594     History of Changes
Other Study ID Numbers: C-009
Study First Received: March 22, 2007
Last Updated: January 12, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:
ITP

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
 Dexamethasone acetate
Methylprednisolone acetate
Prednisolone acetate
Dexamethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Dexamethasone 21-phosphate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics

ClinicalTrials.gov processed this record on May 23, 2013