Phase 3
N=123
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT02077192 ↗Enrolled (actual)
123
Serious AEs
27.6%
Results posted
Dec 2023
Primary outcome: Primary: 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 — 15.4 Percentage of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fostamatinib Disodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
15.4 | — |
| PRIMARY 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 |
2.3 | — |
| SECONDARY Duration of Platelet Response Based on Platelet Count and Rescue Medication |
127.0 | — |
| SECONDARY Percentage of Subjects in Whom a Reduction in the Dose of Concomitant ITP Therapy Can be Achieved While Maintaining an Adequate Platelet Count |
— | — |
Summary
The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02077192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.