Phase 3
N=76
A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT02076399 ↗Enrolled (actual)
76
Serious AEs
17.1%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) — 9; 0 Participants — p=0.0261
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
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24) |
9; 0 | 0.0261 sig |
| SECONDARY Number of Participants With Platelet Count ≥ 50,000/µL at Week 12 |
11; 0 | — |
| SECONDARY Number of Participants With Platelet Count ≥ 50,000/µL at Week 24 |
8; 0 | — |
| SECONDARY Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12. |
4; 0 | — |
| SECONDARY Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24. |
4; 0 | — |
| SECONDARY Mean of the ITP Bleeding Score (IBLS) |
0.13; 0.14 | 0.6642 |
| SECONDARY Mean of World Health Organization (WHO) Bleeding Scale |
0.61; 0.46 | 0.3365 |
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 (NCT02076399). 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.