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A randomized, placebo-controlled, phase II study of obeticholic acid for primary sclerosing cholangitis
- Source :
- Journal of hepatology, Journal of hepatology, vol 73, iss 1
- Publication Year :
- 2020
-
Abstract
- Background & Aims: Primary 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. Methods: AESOP 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<br />Lay summary Primary sclerosing cholangitis (PSC) is a long-term disease that damages the bile ducts in the liver over time. In the AESOP clinical study in patients with PSC, obeticholic acid reduced serum alkaline phosphatase (a potential marker of disease severity) during an initial 24-week treatment period. The result was sustained during the 2-year, long-term extension of the study. The most common side effect of obeticholic acid in the study was itchy skin, which is consistent with earlier clinical studies.<br />Graphical Abstract
- Subjects :
- Liver Cirrhosis
0301 basic medicine
Male
Cholagogues and Choleretics
AESOP Study Investigators
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Liver Function Tests
Cholestasis
Farnesoid X receptor
Ursodeoxycholic acid
education.field_of_study
Liver Cirrhosis, Biliary
Liver Disease
Biliary
Obeticholic acid
Middle Aged
Treatment Outcome
6.1 Pharmaceuticals
Public Health and Health Services
030211 gastroenterology & hepatology
Female
Patient Safety
Drug
Drug Monitoring
medicine.drug
medicine.medical_specialty
Side effect
Bilirubin
Clinical Trials and Supportive Activities
Population
Clinical Sciences
Cholangitis, Sclerosing
Placebo
Chenodeoxycholic Acid
Article
Primary sclerosing cholangitis
Dose-Response Relationship
03 medical and health sciences
Rare Diseases
Double-Blind Method
Clinical Research
Internal medicine
medicine
Humans
education
Hepatology
Dose-Response Relationship, Drug
Gastroenterology & Hepatology
business.industry
Pruritus
Evaluation of treatments and therapeutic interventions
medicine.disease
Alkaline Phosphatase
eye diseases
030104 developmental biology
chemistry
Digestive Diseases
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Journal of hepatology, Journal of hepatology, vol 73, iss 1
- Accession number :
- edsair.doi.dedup.....9a5e016f8f9d08cb8dae3ba936d34c09