- Primary biliary cirrhosis
A Phase IIIb, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects With Primary Biliary Cirrhosis (IRB no. 43035)
This study focuses on patients who have primary biliary cholangitis (PBC), a progressive liver disease caused by a buildup of bile that results in damage to the bile ducts that drain bile from the liver. The purpose of the study is to evaluate the investigational use of a drug called obeticholic acid (also known as OCA) and its effect on PBC when given with ursodeoxycholic acid. OCA is a man-made version of a natural compound produced in the liver called bile acid. Researchers aim to determine the safety and effectiveness of OCA in delaying specific medical conditions or health-related issues that can occur in patients with PBC.
The current standard of care for adults with PBC is ursodeoxycholic acid for an indefinite length of time. In this study, researchers will compare OCA to the standard treatment to learn which is more effective.
Key Inclusion Criteria
- Definite or probable PBC diagnosis
- At least 18 years old
- A mean total bilirubin greater than upper limit of normal (ULN) and ≤3 X ULN or an alkaline phosphatase >5 X ULN
Key Exclusion Criteria
- History or presence of other concomitant liver diseases
- Presence of clinical complications of PBC or clinically significant liver decompensation
- Pregnant, plan to become pregnant or lactating
Vinay Sundaram, MD