Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
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|ClinicalTrials.gov Identifier: NCT02244944|
Recruitment Status : Terminated (Failure to recruit)
First Posted : September 19, 2014
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nonalcoholic Fatty Liver Disease (NAFLD)||Drug: EZ-Urso combination therapy||Phase 2|
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 nonalcoholic fatty liver disease (NAFLD) by magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound, including those diagnosed with nonalcoholic steatohepatitis (NASH). Subjects will be consented, blood collected and a MRI conducted on the first visit. Patients will be advised on the proper use of the study drug and given the first three month's supply of the study drug to take home with them. For the remaining three months, study drug will be delivered by US mail along with return packaging for the prior three month's study medication in order to monitor compliance. Patients will be called routinely to encourage compliance, retention, and monitor side effects or adverse events. After six months of study drug administration, subjects will return for a follow-up visit. Blood will be drawn, an MRI will be obtained and a post-study questionnaire will be administered.
Duration of Patient Enrollment: 6 months Duration of Study: 18 months
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
U.S. FDA Resources
Experimental: EZ-URSO Combination Therapy
Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.
Drug: EZ-Urso combination therapy
Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
- Reduction in Serum Alanine Transaminase (ALT) [ Time Frame: 6 months ]Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)
- Increase in Plasma Lathosterol [ Time Frame: 6 months ]Determine if Ezetimibe-Ursodiol combination therapy promotes a net-negative sterol balance as evidenced by an increase in the cholesterol synthesis intermediate, lathosterol, in plasma.
- Reduction in Hepatic Fat Fraction [ Time Frame: 6 months ]Determine if Ezetimibe-Ursodiol combination therapy reduces total fat in the liver as assessed by MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244944
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Gregory Graf, PhD||University of Kentucky|