GlaxoSmithKline 2009.
Trial name or title | Efficacy and safety study of eltrombopag in pediatric patients with thrombocytopenia from chronic ITP (PETIT) |
Methods | Phase II, multi‐center, 3‐part, staggered cohort, open‐label and double‐blind, randomized, placebo‐controlled study |
Participants | Chronic ITP, a history of ITP for at least 6 months, PLT ≤ 30 × 109/l, one or more prior treatments for ITP, the dose of maintenance immunosuppressive regimens, primarily glucocorticoids must have been stable for at least 1 month, between 1 year and < 18 years of age |
Interventions | Eltrombopag versus placebo |
Outcomes | Primary outcome measure: overall platelet response Secondary outcome measures: incidence of adverse events, incidence of bleeding, incidence of requiring rescue therapy |
Starting date | September 2009 |
Contact information | ClinicalTrials.gov identifier: NCT00908037 |
Notes | Study supported by GlaxoSmithKline |
ITP: idiopathic thrombocytopenic purpura PLT: platelet count