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A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.
This is a two part, double-blind, randomized, placebo-controlled and open-label Phase III study to investigate the efficacy, safety and tolerability of eltrombopag in pediatric patients with previously treated chronic ITP. In Part 1, patients will be randomized to receive eltrombopag or placebo in a 13-week double-blind, placebo-controlled treatment period. After completing Part 1, patients will begin Part 2, in which they will receive eltrombopag in an open-label manner during a 24-week treatment period.
Age
1 - 17 years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
St. Petersburg, Florida, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina
GSK Investigational Site
Brno, Czechia
GSK Investigational Site
Olomouc, Czechia
GSK Investigational Site
Ostrava, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Start Date
March 1, 2012
Primary Completion Date
January 1, 2014
Completion Date
January 1, 2014
Last Updated
March 10, 2015
92
ACTUAL participants
Eltrombopag
DRUG
Placebo
DRUG
Lead Sponsor
GlaxoSmithKline
Data Source & Attribution
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