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
Keywords: elective invasive procedure. platelet transfusion chronic liver disease-related thrombocytopenia platelets thrombopoietin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 292
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: placebo, once daily, oral arm 2: 75 mg, once daily, oral

Interventions: intervention 1: Eltrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: 75 mg, once daily, oral intervention 2: placebo, once daily, oral

Protocol document: