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Pediatric eltrombopag pharmacokinetics in severe aplastic anemia
2015-003166-91Phase 2
Key facts
- Status
- Unknown
- Start
- Jul 2017
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- eltrombopag
- Conditions
- aplastic anemia
01
Overview
Phase 2, open-label trial of eltrombopag in aplastic anemia (2 cohorts), sponsored by Novartis. Primary endpoint: Eltrombopag pharmacokinetics at the highest dose level. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-labelSingle group
Cohort A
Pediatric patients with relapsed/refractory severe aplastic anemia or recurrent aplastic anemia receiving oral eltrombopag.
Cohort B
Pediatric patients in the second study cohort receiving oral eltrombopag; exact subgroup details are not fully provided in the source excerpt.
03
Who it enrols
Pediatric patients with refractory, relapsed, or treatment-naive severe aplastic anemia, or recurrent aplastic anemia, were eligible. Patients with specified prior and/or active medical history were excluded.
04
Endpoints
Primary
Eltrombopag pharmacokinetics at the highest dose level
Secondary
Safety and tolerability
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