High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

Last updated: January 12, 2011
Sponsor: Cooperative Study Group A for Hematology
Overall Status: Completed

Phase

3

Condition

Anemia

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Lupus

Treatment

N/A

Clinical Study ID

NCT00451594
C-009
  • Ages > 16
  • All Genders

Study Summary

To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.

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.

Study Design

Total Participants: 157
Study Start date:
September 01, 2005
Estimated Completion Date:
December 31, 2010

Study 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).

Connect with a study center

  • Asan Medical Center

    Seoul, Songpa-gu 138-736
    Korea, Republic of

    Site Not Available

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