Phase 3
N=74
A Efficacy and Safety Study of Fostamatinib in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT02076412 ↗Enrolled (actual)
74
Serious AEs
14.9%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Stable Platelet Response of at Least 50,000/µL — 9; 1 Participants — p=0.1519
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fostamatinib Disodium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Aug 2016
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 |
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).
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). 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.