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Completed

NCT Number: NCT00451594

High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

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

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

Pulse high dose dexamethasone (Arm 1)

  • Patients will receive 40 mg of oral dexamethasone daily for four consecutive days.
  • Other treatments should be considered if there was a platelet count of 30X109/L or less by day 14
  • If the patient had a platelet count of more than 30X109/L after four days of dexamethasone treatment, no further treatment will be given.
  • 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.
  • Patients whose platelet counts can not be maintained at 30X109/L will be offered other treatments.

Other names: Dexa

Prednisolone

Drug

Conventional dose prednisone (Arm 2)

  • 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.
  • Guideline of prednisone tapering Duration of prednisone treatment: 3-6 months

Other names: PD

Primary outcomes

  1. response rate and platelet count

    Time frame: 6 years

    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

Sponsors and collaborators

Lead sponsor

Cooperative Study Group A for Hematology

Network

Registry information

Official study title

A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Mar 23, 2007
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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