NCT00678587

Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures

Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

Conditions

• Non-alcoholic Steatohepatitis
• Chronic Liver Disease
• HCV
• NASH - Nonalcoholic Steatohepatitis
• HIV Infection
• Thrombocytopenia
• Hepatitis C Virus
• HBV
• Human Immunodeficiency Virus
• Liver Diseases
• Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	Eltrombopag	75 mg, once daily, oral
DRUG	Placebo	placebo, once daily, oral

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-05-15
• Last updated: 2018-10-12
• Results posted: 2010-11-08

Locations

107 sites across 13 countries: United States, Argentina, Belgium, Canada, France, India, Italy, Pakistan, Poland, Russia, South Korea, Spain, Taiwan