Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Rigel Pharmaceuticals
- Study ID
- NCT02077192
- Phase
- PHASE3
- Status
- Completed
Conditions
- Immune Thrombocytopenic Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fostamatinib Disodium — DRUGFostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Study Details
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
Key Dates
- Start date
- Oct 31, 2014
- Status verified
- Dec 2023
- Primary completion
- Jun 2, 2020
- Completion
- Jun 2, 2020
Study Design
- Enrollment
- 123 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Fostamatinib DisodiumFostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Primary Outcome Measure
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 [ Time Frame: Up to 12 months ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arizona Oncology Associates | Tucson | Arizona | 85710 | - |
| Bleeding & Clotting Disorders Institute | Peoria | Illinois | 61615 | - |
| Horizon Oncology Research, Inc | Lafayette | Indiana | 47905 | - |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | - |
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10065 | - |
| Weill Cornell Medicine | New York | New York | 10065 | - |
| East Carolina University, Brody School of Medicine | Greenville | North Carolina | 27834 | - |
| W.G. "Bill" Hefner VA Medical Center | Salisbury | North Carolina | 28144 | - |
| Signal Point Clinical Research Center LLC | Middletown | Ohio | 45042 | - |
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