Phase 3
Completed N=74
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenic Purpura
Source: ClinicalTrials.gov NCT02076412 ↗
Enrolled (actual)
74
Serious AEs
14.9%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Stable Platelet Response of at Least 50,000/µL — 9; 1 Participants — p=0.1519
◆ Published Evidence
Established
62citations · ~12 / year
Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.
Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).
Linked Publications
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Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stable Platelet Response of at Least 50,000/µL |
9; 1 | 0.1519 |
| SECONDARY Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 |
12; 3 | — |
| SECONDARY Number of Participants With Platelet Count ≥ 50,000/µL at Week 24 |
8; 1 | — |
| SECONDARY Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12 |
6; 1 | — |
| SECONDARY Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24 |
3; 0 | — |
| SECONDARY Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS) |
0.04; 0.06 | 0.4927 |
| SECONDARY Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale |
0.26; 0.38 | 0.2499 |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of persistent/chronic ITP for at least 3 months
- Average platelet count 35, 000 unless as a result of rescue therapy) from at least 3 qualifying counts
Exclusion Criteria
- Clinical diagnosis of autoimmune hemolytic anemia
- Uncontrolled or poorly controlled hypertension
- History of coagulopathy including prothrombotic conditions
Data sourced from ClinicalTrials.gov (NCT02076412) and the linked publication. 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. Informational only — not medical advice.