OACS-2
Research type
Research Study
Full title
Obeticholic acid for the Amelioration of Cognitive Symptoms trial- 2
IRAS ID
280025
Contact name
David Jones
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2020-004613-12
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
The aim of OACS-2 is to evaluate the effect of Obeticholic Acid in patients with a recent diagnosis of Primary Biliary Cholangitis (PBC) who also experience cognitive symptoms around memory and problem solving.
This study is based on results of preclinical studies in mice where Obeticholic acid was shown to reverse both the liver disease and age related cognitive impairment.
Obeticholic acid is currently licence for the treatment of PBC. It can be treated in combination with Ursodeoxycholic acid (UDCA) another drug used to treat with PBC or on its own. This study will include patients who are responders to UDCA and also non-responders to UDCA. Obeticholic acid has a well-known safety profile.
The aim of OACS-2 is to treat patients with recent onset PBC with Obeticholic acid to determine whether Obeticholic acid can improve cognitive symptoms in patients with PBC.OACS-2 is a multicentre randomised controlled trial involving adults between the ages of 18 and 65 years with recent onset PBC. The study aims to recruit 25 patients. Patients will be treated with either Obeticholic acid or placebo for up to 6 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
21/NE/0084
Date of REC Opinion
4 May 2021
REC opinion
Favourable Opinion