Cirrhosis
Please note: the following ELEVATE study is currently on hold.
ELEVATE: ELtrombopag Evaluated for its Ability to overcome Thrombocytopenia and Enable procedures
Purpose
The purpose of the study is to demonstrate the ability of eltrombopag, compared to placebo, to reduce the proportions of subjects with chronic liver disease and low platelet count who receive platelet transfusions administered prior to, during, and up to 7 days following elective procedure.
Study Design
This is a double blind, randomized 1:1, placebo controlled, multi-center study. Study subjects will be randomized to either 75 mg eltrombopag doses once daily for 14 days or matched placebo control.
Main Inclusion Criteria
- Adult males and females > 18 years of age
- Chronic liver disease
- Platelet count < 50,000
- Stable hemoglobin > 8 g/dL
- Undergoing an elective invasive procedure for treatment of liver disease.
Main Exclusion Criteria
- Evidence of portal vein thrombosis on abdominal imaging within 3 months of study start.
Study Visits
- Screening visit
- Baseline visit - initiation of eltrombopag/placebo
- Weekly visit on therapy and after procedure for 4 weeks.
Questions or referrals: please contact Diane White: (734) 763-6647 or dfwhite@umich.edu or Hellan Kang, MD: (734) 936-7511 or hellank@med.umich.edu.
