OACS-1
Research type
Research Study
Full title
Obeticholic acid for the Amelioration of Cognitive Symptoms trial - 1
IRAS ID
270777
Contact name
David Jones
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2019-004776-19
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
The aim of OACS-1 is to evaluate the effect of Obeticholic Acid (OCALIVA) in patients with a diagnosis of Primary Biliary Cholangitis (PBC) who also experience issues with cognitive function around memory and problem solving.
The study is based on results of preclinical studies in mice where OCALIVA was shown to reverse both the liver disease and related cognitive impairment.
OCALIVA is currently licenced 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 treat patients who are responders to UDCA and also non-responders to UDCA. It has a well-known safety profile. The aim of the study is to treat patients with OCALIVA at earlier stage in the disease course to determine whether OCALIVA can improve cognitive function in patients with PBC.
OACS-1 is a single centre randomised controlled double blind trial involving adults between the ages of 18 and 65 years with established diagnosis of PBC. The study aims to recruit 40 patients (20 to each arm). Patients will be treated with the either OCALIVA or placebo for up to 6 months.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0248
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion