Phase 2
N=18
Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)
Purpura, Thrombocytopenic, Idiopathic
Bottom Line
View on ClinicalTrials.gov: NCT00706342 ↗Enrolled (actual)
18
Serious AEs
44.4%
Results posted
Aug 2014
Primary outcome: Primary: Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2 — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fostamatinib Disodium / R935788 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2 |
8 | — |
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6 |
5 | — |
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12 |
5 | — |
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24 |
4 | — |
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12 |
5 | — |
| PRIMARY Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24 |
2 | — |
Summary
The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).
Eligibility Criteria
Inclusion Criteria
- Patients must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form prior to admission to this study.
- Patients may be male or female, between the ages of 18 75. Men, if sexually active, must agree to use at least one medically acceptable form of birth control. Women of childbearing potential must have a negative urine pregnancy test, and agree to use two independent methods of birth control, if sexually active.
- Patients must have a diagnosis of chronic refractory ITP for at least 3 months. Chronic refractory ITP is defined as:
- Platelet count 1.5xULN are excluded.
Data sourced from ClinicalTrials.gov (NCT00706342). 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.