High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

Cooperative Study Group A for Hematology

Status and phase

Completed

Phase 3

Conditions

Idiopathic Thrombocytopenic Purpura

Treatments

Drug: Dexamethasone

Drug: Prednisolone

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00451594

C-009

Details and patient eligibility

About

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

Full 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).

Enrollment

157 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.