A phase 3, double-blind, randomized, placebo-controlled, multicenter study to evaluate the efficacy and safety of Obeticholic Acid in subjects with compensated cirrhosis due to nonalcoholic steatohepatitis.
Enrollment Status: OPEN
Drug: Obeticholic Acid
This is a phase 3 study for patients with Stage 4 fibrotic liver disease (cirrhosiss) to evaluate the safety and effectiveeness of Obeticholic Acid. The study has two (2) parts and lasts for two (2) years. To be qualified for the study, participants will need to complete two screening visits. During those visits, particpants will be asked about their medical history, medication use, obtain vitals signs and laboratory blood draws, undergo a firbroscan, liver biopsy, esophagogastroduodenoscopy (EGD), liver ultrasound, physical exam and electrocardiogram (EKG or ECG). Patients who pass both screening visits will be enrolled into the study to receive either an oral placebo medication or oral Obeticholic Acid medication in Part 1 of the trial. Because this is a double blind study, the physician, research staff nor the patient will know which medication they receive. Participants have a greater than 65% chance of receiving the study medication (Obticholic Acid). If participants complete Part 1 of the trial, they voluntarily enroll into Part 2 of the trial where every participant will receive the study medication. As with all clinical research trials, participants may discontiue study drug and withdrawal from the trial at anytime without penalty to your medical care.