Trial Information

Summary: A study for adults with refractory chronic ITP (Immune Thrombocytopenic Purpura) evaluating the safety and efficacy of SB-497115, an oral thrombopoietin receptor agonist.

This research study is for people over the age of 18 years who have been diagnosed with ITP (Immune Thrombocytopenic Purpura) for at least six months. To be eligible for this study, you must have been treated unsuccessfully with medications and/or splenectomy. Additional criteria will be assessed by the study physician. Qualified study participants will be asked to take the oral study drug (SB497115 vs Placebo) once a day. A total of 11 clinic visits will be scheduled during which participants may undergo evaluations including study-related physical examinations, medical history review, and laboratory tests (i.e. platelet counts). All study-related medical exams, laboratory tests, and study medication will be provided to participants at no cost. If you are interested in learning more about this study; please visit www.itpstudy.com/ctw

Inclusion Criteria:

• At least 18 years old
• Chronic low platelet count for 6 months
• Failed at least one treatment for chronic low platelet count
• No history of heart attack or abnormal heart function.
• Use of acceptable contraceptives.

Exclusion Criteria:

• History of thrombosis within 1 year
• Females who are pregnant
• History of alcohol/drug abuse or dependence within 1 year
• Treatment with an investigational drug within 30 days
• History of HIV infection; active infection with Hepatitis B or C

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Trial listings updated: June 1, 2008 at 5:44:40 AM