Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Liver Cirrhosis, Biliary

In brief

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.

Key facts

Study ID

NCT02308111

Run by

Intercept Pharmaceuticals

People needed

334

Starts

2014-12-26

Expected to finish

2021-12-23

Last updated by the study team

2023-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History or presence of other concomitant liver diseases including:
• Hepatitis C virus infection
• Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
• Primary sclerosing cholangitis (PSC)
• Alcoholic liver disease
• Definite autoimmune liver disease or overlap hepatitis
• Nonalcoholic steatohepatitis (NASH)
• Gilbert's Syndrome
• Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
• History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria
• Cirrhosis with complications, including history (within the past 12 months) or presence of:
• Variceal bleed
• Uncontrolled ascites
• Encephalopathy
• Spontaneous bacterial peritonitis
• Known or suspected HCC
• Prior transjugular intrahepatic portosystemic shunt procedure
• Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 μmol/L)
• Mean total bilirubin >5x ULN
• Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
• Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
• If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
• Known history of human immunodeficiency virus infection
• Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
• Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• University of California Davis, Davis Medical Center — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Denver and Hospital — Aurora, Colorado, United States
• UF Hepatology Research at CTRB — Gainesville, Florida, United States
• Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• University of Louisville, Medical Dental Complex — Louisville, Kentucky, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• UMass Medical School — Worcester, Massachusetts, United States
• Henry Ford Health System — Novi, Michigan, United States
• Minnesota Gastroenterology, P.A. — Saint Paul, Minnesota, United States
• Southern Therapy and Advanced Research (STAR) — Jackson, Mississippi, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Saint Louis University Gastroenterology & Hepatology — St Louis, Missouri, United States
• Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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