Trial Information

Summary: RAISE (RAndomized placebo-controlled ITP Study with Eltrombopag)

A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP) [TRA102537]

This study is for people who have chronic idiopathic thrombocytopenic purpura (ITP) (persistent low blood platelets). The purpose of this study is to see if the study drug eltrombopag olamine (SB-497115-GR) is safe and effective when used to treat people with chronic ITP.

Study participation will last about 1 year which includes a screening visit, 6 months of study treatment and about 6 months of follow up.

Study participants will be given either eltrombopag or a placebo (a tablet that looks like eltrombopag but does not contain any active medication). Participants will be randomly (like the flip of a coin) assigned to 1 of 2 study groups:
-Group 1: Eltrombopag once daily for 6 months
-Group 2: Placebo once daily for 6 months

All study drugs and procedures needed for this study will be provided at no cost. Compensation will be provided.

Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate if you
-are 18 years of age or older
-have been diagnosed with chronic ITP
-have previously received one or more prior ITP therapies

You will not be eligible to participate if you
-are pregnant or breastfeeding
-have HIV, or hepatitis B or C

If you would like to learn more about participating in this study, please send an e-mail message using the form below.