Initial Treatment of Patients With Immune Thrombocytopenic Purpura

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Immune Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT00991939

Run by

Carelon Research

People needed

8

Starts

2010-01-01

Expected to finish

2013-03-01

Last updated by the study team

2014-02-14

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must meet criteria for a diagnosis of ITP as specified by ASH guidelines
• Must be within 30 days after diagnosis of ITP at the time of randomization (diagnosis of ITP starts with first platelet count ≤ 100,000/μl)
• Platelet count ≤ 30,000/μl at the time ITP is diagnosed, and/or at some time between the diagnosis of ITP and study entry
• Platelet count ≤ 150,000/μl at the time of randomization
• Age ≥ 15 years
• If bone marrow examination is available, it must be compatible with ITP
• Subjects, or their legal guardians, must have the ability to provide informed consent

You may not qualify if…

• Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8 weeks.
• Known HIV infection
• Known HCV infection
• Known systemic lupus erythematosus
• Pregnancy or breastfeeding
• Insulin-requiring diabetes mellitus
• Previous exposure to prednisone for ITP at a dose ≥ 1.5 mg/kg prednisone/day for ≥ 1 week prior to study entry
• Ongoing use of treatments that are known to inhibit platelet function, e.g. aspirin
• Anything that in the opinion of the investigator is likely to interfere with participation in the study
• Persons previously randomized in the ITP\^2 study
• Persons currently enrolled in other interventional clinical trials
• Exposure to thrombopoietic agent prior to study entry
• Previous exposure to dexamethasone for the treatment of ITP at a dose of 30 mg/day or greater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for at least four days

Where it is running

• Tulane University — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Weill Medical College, Cornell University — New York, New York, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Presbyterian and Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Gundersen Clinic — La Crosse, Wisconsin, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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