Initial Treatment of Patients With Immune Thrombocytopenic Purpura

Summary

This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with prednisone.

Conditions

• Immune Thrombocytopenic Purpura

Interventions

DRUG

Dexamethasone USP Micronized

The dose for dexamethasone is 30 mg/day for patients \< 60 kg and 40 mg/day for patients \> 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.

DRUG

Prednisone

Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients \> 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients \< 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Carelon Research

  lead OTHER

Principal Investigators

• Susan F Assmann, PhD · Carelon Research

• James Bussel, MD · Weill Medical College, Cornell University

• Alvin Schmaier, MD · Case Western Reserve University

• Jodi Segal, MD · Johns Hopkins University

• Terry Gernsheimer, MD · University of Washington

• Eliot Williams, MD · University of Wisconsin, Madison

• Ellis Neufeld, MD · Boston Children's Hospital

• Judith Lin, MD · Brigham and Women's Hospital

• Thomas Ortel, MD · Duke University

• David Kuter, MD · Massachusetts General Hospital

• Cindy Leissinger, MD · Tulane University

• Ann Zimrin, MD · University of Maryland

• Nigel Key, MD · University of North Carolina, Chapel Hill

• James George, MD · The University of Oklahoma

• Michele Lambert, MD · Children's Hospital of Philadelphia

• Joseph Kiss, MD · University of Pittsburgh

• Bruce Sachais, MD, PhD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• United States

Study Locations