Initial Treatment of Patients With Immune Thrombocytopenic Purpura

PHASE3TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

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.

Trial Locations (18)

10021

Weill Medical College, Cornell University, New York

15213

University of Pittsburgh Presbyterian and Shadyside Hospital, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

University of Pennsylvania, Philadelphia

21201

University of Maryland, Baltimore

21287

Johns Hopkins Hospital, Baltimore

27514

University of North Carolina Hospitals, Chapel Hill

27710

Duke University, Durham

44106

Case Western Reserve University, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

53792

University of Wisconsin, Madison

54601

Gundersen Clinic, La Crosse

70112

Tulane University, New Orleans

73104

The University of Oklahoma Health Sciences Center, Oklahoma City

98195

University of Washington Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02115

Brigham & Women's Hospital, Boston

Children's Hospital Boston, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Carelon Research

OTHER