Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Completed · Phase 3

Conditions studied: Immune Thrombocytopenic Purpura

In brief

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP

Key facts

Study ID

NCT02077192

Run by

Rigel Pharmaceuticals

People needed

123

Starts

2014-10-01

Expected to finish

2020-06-02

Last updated by the study team

2023-12-11

Who can join

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

You may qualify if…

• Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
• Able and willing to give written informed consent

You may not qualify if…

• Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
• Poorly controlled hypertension during Study C935788-047 or Study C935788-048
• Significant infection, an acute infection such as influenza, or known inflammatory process

Where it is running

• 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
• Weill Cornell Medicine — New York, New York, United States
• East Carolina University, Brody School of Medicine — Greenville, North Carolina, United States
• W.G. "Bill" Hefner VA Medical Center — Salisbury, North Carolina, United States
• Signal Point Clinical Research Center LLC — Middletown, Ohio, United States
• Concord Repatriation General Hospital — Concord, 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
• The Alfred — Melbourne, Victoria, Australia
• Perth Blood Institute — Nedlands, Western Australia, Australia
• Hanusch-Krankenhaus Wiener Gebietskrankenkasse — Vienna, Austria
• Specialized Hospital for Active Treatment of Hematology Diseases, EAD, Sofia, Department of Chemotherapy, Hemotherapy and Blood Inherited Diseases to Clinic of Clinical Hematology; — Sofia, BG, Bulgaria
• UMHAT Dr. Georgi Stranski, EAD, Pleven, Clinic of Hematology — Pleven, Bulgaria
• UMHAT Aleksandrovska, EAD — Sofia, Bulgaria
• MHAT Hristo Botev, AD, Vratsa, First Internal Department — Vratsa, Bulgaria
• Hamilton Health Sciences Corporation — Hamilton, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Fakultni nemocnice Brno — Brno, Czechia
• Fakultni nemocnice Ostrava — Ostrava-Poruba, Czechia
• Arizona Oncology Associates — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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