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
Study of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
Sponsor: Intercept Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAR5418
Contact: Ava Farrell: 212-305-0914 / af3025@cumc.columbia.edu
Additional Study Information: The Sponsor is conducting this study to find out how safe and effective the investigational drug (alsocalled a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several countries (including the United States, Canada and Europe) for the treatment of another form of chronic liver disease called Primary Biliary Cholangitis (PBC). In this study, OCA is an investigational drug (study drug) because it has not been approved to treat cirrhosis as the result of NASH, or cirrhosis that is almost certainly the result of NASH. There will be the following two phases to this study: Double-Blind Phase (which will last 12 Months): Subjects who are eligible will be placed randomly in one of two groups to receive either placebo or OCA. Subjects will have a 50% chance of being placed into either group. Subjects will receive oral 10mg of OCA or placebo for the first 3 months. At Month 3, subjects will be adjusted to oral 25 mg of OCA once daily unless there are safety concerns. Efficacy, safety, and laboratory assessments will be evaluated at clinical visits at Day 1, monthly for the initial 6 months (Month 1 through Month 6 Visits), Month 9, and Month 12. Open-Label Extension (up to 24 Months): Subjects who complete the Double-Blind Month 12 Visit are eligible to enroll into the Open Label Extension (OLE) portion of the study for the evaluation of safety. All subjects will receive OCA upon entry into the OLE. Subjects who received placebo during the Double-Blind Phase will receive OCA 10 mg daily for 3 months and adjust to OCA 25 mg daily in the same manner that was applied during the Double-Blind Phase. Subjects who received OCA during the Double Blind phase will continue the same dosing regimen they received at the end of the Double-Blind Phase. A total of about 540 people are expected to participate in
This study is closed
Investigator
Julia Wattacheril, MD, MPH
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Have you received a diagnosis of NASH? Yes No
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For more information, please contact:
Ava Farrell
af3025@cumc.columbia.edu
212-305-0914