Taking part in this trial involves 5 hospital appointments over a year. There will also be one planned phone call.

Participants will be prescribed obeticholic acid or placebo tablets for around 6 months and will continue to be followed up as part of the trial for another 6 months. This is to see if any benefits that arise from taking the trial medicine continue after the participant stops taking the medicine. The total time on the trial will be around 1year. Participants will give blood samples and complete questionnaires and will also be asked to have a Fibroscan (a normal part of the assessment of people with PBC).

There will also be an opportunity to take part in an optional liver biopsy sub-study of OPERA.

The study is running from 2023 – 202X and will involve 106 patients.

From the start of OPERA, PBC patients have contributed to the design of the study and have informed the content of the patient information sheets. PBC patients continue to input into the running of the study as members of the trial steering committee.

To find out more about the study and what it might mean for someone to take part, you can access the patient information leaflet for the study here: OPERA Patient information sheet