A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)



Status:Completed
Conditions:Infectious Disease, Hematology, Hematology, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:July 14, 2014
End Date:April 21, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

The purpose of this study is to determine whether fostamatinib is safe and effective in the
treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).


Inclusion Criteria:

- Clinical diagnosis of persistent/chronic ITP for at least 3 months.

- Average platelet count < 30,000/µL (and none > 35,000 unless as a result of rescue
therapy) from at least 3 qualifying counts

Exclusion Criteria:

- Clinical diagnosis of autoimmune hemolytic anemia

- Uncontrolled or poorly controlled hypertension

- History of coagulopathy including prothrombotic conditions
We found this trial at
14
sites
University of Utah Health Sciences Center
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Lakeland Regional Cancer Center
3525
Lakeland, Florida 33805
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Lakeland, FL
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University of Southern California
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Center for Cancer & Blood Disorders
6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Concord Repatriation General Hospital
Concord, New South Wales
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Concord,
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Pitt County Memorial Hospital
916 South Memorial Drive
Greenville, North Carolina 27858
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Greenville, NC
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Horizon Oncology Research, Inc.
Lafayette, Indiana
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Lafayette, IN
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Signal Point Clinical Research Center, LLC
Middletown, Ohio 45042
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Middletown, OH
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
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New York, NY
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The Bleeding and Clotting Disorders Institute
Peoria, Illinois 61614
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Peoria, IL
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Bill Hefner VA Medical Center
1601 Brenner Avenue
Salisbury, North Carolina 28144
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Salisbury, NC
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Arizona Oncology Associates
Tucson, Arizona 85745
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Tucson, AZ
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