drugset / Trial / NCT02201290
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Open-labelTreatment
Summary
This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose was based on the subject's dose at the end of the TRA115450 study. The maximum dose was 75 mg daily.
Timeline
- Start
- 2013-06-18
- Primary completion
- 2017-07-04
- Completion
- 2017-07-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eltrombopag | Small molecule | 12.5 mg | Oral |
| Subject | Eltrombopag | Small molecule | 25 mg | Oral |
| Subject | Eltrombopag | Small molecule | 50 mg | Oral |
| Subject | Eltrombopag | Small molecule | 75 mg | Oral |