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
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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from
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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University of Utah Health Sciences Center
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Arizona Oncology Associates
Tucson, Arizona 85745
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Tucson, AZ
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