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

Completed · Phase 3 · Has a placebo group

Conditions studied: Immune Thrombocytopenic Purpura

In brief

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

Key facts

Study ID

NCT02076399

Run by

Rigel Pharmaceuticals

People needed

76

Starts

2014-07-14

Expected to finish

2016-04-21

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Clinical diagnosis of autoimmune hemolytic anemia
• Uncontrolled or poorly controlled hypertension
• History of coagulopathy including prothrombotic conditions

Where it is running

• University of Southern California — Los Angeles, California, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Bleeding & Clotting Disorders Institute — Peoria, Illinois, United States
• Horizon Oncology Research, Inc — Lafayette, Indiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Weill Cornell Medical College/New York Presbyterian Hospital — New York, New York, United States
• Pitt County Memorial Hospital — Greenville, North Carolina, United States
• Bill Hefner VA Medical Center — Salisbury, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Signal Point Clinical Research Center LLC — Middletown, Ohio, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• St George Hospital — Kogarah, New South Wales, Australia
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Prince of Wales Hospital — Randwick, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Launceston General Hospital — Launceston, Tasmania, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• Dept of Haematology, The Alfred Hospital and Monash Medical Centre — Melbourne, Victoria, Australia
• Perth Blood Institute — Nedlands, Western Australia, Australia
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Arizona Oncology Associates — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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