Status:
TERMINATED
Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
Lead Sponsor:
Gregory Graf, PhD
Conditions:
Nonalcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects...
Detailed Description
The study will be conducted as a prospective open label trial with pre- and post-treatment measures for all dependent variables. This trial will enroll subjects with a clinical diagnosis of nonalcohol...
Eligibility Criteria
Inclusion
- Steatosis
- ALT \>1.5 times normal
- ALT/AST ratio \>1.0
- Normal Kidney Function
Exclusion
- Normal ALT within last 6 months
- Advanced fibrosis based on 1) biopsy, if available (Stage 3 or 4 NAFLD), 2) imaging, or 3) lab (platelet count \<150,000)
- Daily alcohol use above 20 g/day for women and 30 g/day for men
- Prescription use of ursodiol, ezetimibe, vitamin E, fish oils, thiazolidinediones, insulin, sulfonylureas, HMG-CoA reductase inhibitors
- Weight loss greater than 15% in past 12 months
- Pregnant or breastfeeding
- Body Mass index greater than 50
- Largest body circumference greater than 160 cm
- Claustrophobia
- Allergy to ezetimibe or ursodiol
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02244944
Start Date
September 1 2014
End Date
September 1 2015
Last Update
February 7 2018
Active Locations (1)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536