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Safety and efficacy of obeticholic acid in patients with compensated NASH

Research Question:
Can Obeticholic acid improve fibrosis and prevent the worsening of NASH when compared with placebo?

Basic Study Information

Purpose:
This study will last 2 years and 3 months with the participant visiting the clinic 22 times. This consists of a 1 year double blind period and an optional 1 year open label period. After the screening period, participants will be randomized into groups of Placebo medication, 10 mg of OCA, or 10-25 mg of OCA. A liver biopsy is required for this study at the screening visit if one has not been completed within 12 months of day 1. This study will also include questionnaires, an EKG of your heart, fasting blood work, vital signs, and physical examinations. All study medication and protocol required procedures are covered by the clinical trial sponsor.

Location: University of Rochester Medical Center
Study Reference #: 1188254

Lead Researcher (Principal Investigator)

Lead Researcher: Jonathan Huang

Study Contact Information

Study Coordinator: Lauren Ott
Phone: (585) 276-3042
Email: lauren_ott@urmc.rochester.edu

Additional Study Details

Number of Visits:  More than 10
Parking:  Reimbursed
Transportation Coverage:  No
Reimbursement:  Yes

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