Phase
Condition
Idiopathic Thrombocytopenic Purpura (Itp)
Thrombocytopenic
Immune (Idiopathic) Thrombocytopenic Purpura (Itp)
Treatment
N/AClinical Study ID
Ages > 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 (diagnosisof 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 betweenthe 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
Exclusion
Exclusion Criteria:
Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8weeks.
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 ≥ 1week 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 withparticipation 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 orgreater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for atleast four days
Study Design
Study Description
Connect with a study center
Tulane University
New Orleans, Louisiana 70112
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Children's Hospital Boston
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Weill Medical College, Cornell University
New York, New York 10021
United StatesSite Not Available
University of North Carolina Hospitals
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Case Western Reserve University
Cleveland, Ohio 44106
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Presbyterian and Shadyside Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
Gundersen Clinic
La Crosse, Wisconsin 54601
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
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