The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
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
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.
Time frame: 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 (Placebo in 047/048 and Fostamatinib 049): Version 2
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.
Time frame: Up to 12 months
Duration of Platelet Response Based on Platelet Count and Rescue Medication
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.
Time frame: Up to 12 months
Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count
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Center for Cancer and Blood Disorders
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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
...and 45 more locations
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.
Time frame: Up to 12 months