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

Phase 3

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Fostamatinib Disodium	Fostamatinib Disodium	Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Fostamatinib in 047/048 or 049):Version 1	Up to 12 months	Percentage of subjects who achieved platelet count of at least 50,000/µL within 12 Weeks of beginning treatment up to 12 months was analyzed among all subjects who received active treatment in one of the prior studies (C788-047 or C788-048), in the current extension study (C788-049), or in both prior and current studies. Treated Population was defined as all enrolled and treated subjects.
Percentage of Subjects Who Achieved Platelet Count of at Least 50,000/µL Within 12 Weeks of Beginning Treatment up to 12 Months (Placebo in 047/048 and Fostamatinib 049): Version 2	Up to 12 months	A within-subject, between-study comparison of platelet counts for subjects who were previously treated with placebo in one of the prior studies (C788-047 or C788-048) was prospectively defined in the protocol (version 2). Achievement of platelet response by 12 weeks and maintenance of platelet response for 12 weeks was analyzed among subjects who had been randomized to placebo in one of the prior studies (C788-047 or C788-048). Treated Population was defined as all enrolled and treated subjects.

Secondary Outcome Measures

Name	Time	Method
Duration of Platelet Response Based on Platelet Count and Rescue Medication	Up to 12 months	The duration of platelet response was defined as the time from when the subject first achieved a platelet count of at least 50,000/µL, until the first of 2 visits with platelet counts \< 50,000/µL that were at least 4 weeks apart without an intervening visit with a platelet count less than equal to (\<=) 50,000/µL unrelated to rescue therapy. Duration of platelet response was analyzed using the Kaplan-Meier method. Treated Population was defined as all enrolled and treated subjects. Here, a number of subjects analyzed included all subjects evaluable for this endpoint.
Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count	Up to 12 months	The percentage of subjects in whom a reduction in the dose of concomitant ITP therapy could be achieved while maintaining an adequate platelet count, the reduction event was clarified to apply only to reductions in the dose of concomitant ITP therapy occurring within a period of platelet response and the reduction event was not be prompted by an adverse event.

Locations (55): Arizona Oncology Associates
🇺🇸
Tucson, Arizona, 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
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
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Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States