1. A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis
- Author
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Kowdley, Kris V, Vuppalanchi, Raj, Levy, Cynthia, Floreani, Annarosa, Andreone, Pietro, LaRusso, Nicholas F, Shrestha, Roshan, Trotter, James, Goldberg, David, Rushbrook, Simon, Hirschfield, Gideon M, Schiano, Thomas, Jin, Yuying, Pencek, Richard, MacConell, Leigh, Shapiro, David, Bowlus, Christopher L, and Investigators, AESOP Study
- Subjects
Clinical Trials and Supportive Activities ,Clinical Research ,Rare Diseases ,Liver Disease ,Patient Safety ,Digestive Diseases ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Alkaline Phosphatase ,Chenodeoxycholic Acid ,Cholagogues and Choleretics ,Dose-Response Relationship ,Drug ,Double-Blind Method ,Drug Monitoring ,Female ,Humans ,Liver Cirrhosis ,Biliary ,Liver Function Tests ,Male ,Middle Aged ,Pruritus ,Treatment Outcome ,Cholestasis ,Farnesoid X receptor ,Ursodeoxycholic acid ,AESOP Study Investigators ,Clinical Sciences ,Public Health and Health Services ,Gastroenterology & Hepatology - Abstract
Background & aimsPrimary sclerosing cholangitis (PSC) is a rare, cholestatic liver disease with no currently approved therapies. Obeticholic acid (OCA) is a potent farnesoid X receptor (FXR) agonist approved for the treatment of primary biliary cholangitis. We investigated the efficacy and safety of OCA in patients with PSC.MethodsAESOP was a phase II, randomized, double-blind, placebo-controlled, dose-finding study. Eligible patients were 18 to 75 years of age with a diagnosis of PSC and serum alkaline phosphatase (ALP) ≥2× the upper limit of normal (ULN) and total bilirubin
- Published
- 2020