High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP

NCT00451594 | Completed Phase 3 DMC

• 1 other identifier: C-009
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• response rate and platelet count

  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

  6 years

Interventions

Dexamethasone DRUG

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.

Also known as: Dexa

Prednisolone DRUG

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

Also known as: PD

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

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

Location

Related Links

• A RANDOMIZED CONTROLLED MULTICENTER TRIAL OF HIGH DOSE DEXAMETHASONE VERSUS CONVENTIONAL DOSE PREDNISONE FOR ADULTS WITH UNTREATED IDIOPATHIC THROMBOCYTOPENIC PURPURA

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone; Absorptiometry, Photon; Prednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sung Hwa Bae, professor

  Daegu Catholic Univertity Hospital, ROK

  PRINCIPAL INVESTIGATOR

• Jung-Hee Lee, professor

  Asan Medical Center, ROK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 13, 2011

Record last verified: 2011-01

Locations

KR (1)