drugset / Trial / NCT00991939
Initial Treatment of Patients With Immune Thrombocytopenic Purpura
Phase 3
Terminated
8 enrolled
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with prednisone.
Timeline
- Start
- 2010-01
- Primary completion
- 2013-03
- Completion
- 2013-03
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was closed due to accrual futility there were only a total of 8 subjects enrolled.”
registry p = 1.00; Difference of proportions 0 (95% CI -0.975 to 0.708); Fisher Exact NCT00991939 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone USP Micronized | Small molecule | 30 mg | — |
| Subject | Dexamethasone USP Micronized | Small molecule | 40 mg | — |
| Comparator | Prednisone | Other / unclassified | 60 mg | — |
| Comparator | Prednisone | Other / unclassified | 80 mg | — |