OPERA
Research type
Research Study
Full title
Optimising Primary Therapy in Primary Biliary Cholangitis
IRAS ID
1006087
Contact name
David Jones
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2022-000050-28
ISRCTN Number
ISRCTN17176388
Research summary
Primary biliary cholangitis (PBC) is a rare liver disease. A number of treatments exist, which slow the rate that liver disease gets worse. However, at the moment, doctors have to wait for one treatment to fail before adding in a second. As a result, many people with PBC develop symptoms and some go on to need a liver transplant.
The aim of the OPERA trial is to see if people who are newly/recently diagnosed with PBC have a better outcome if they receive two medicines from the start rather than one. Importantly, this trial will recruit people who are at risk of not responding to the one therapy alone (ursodeoxycholic acid, UDCA or “urso”). The second, additional medicine offered as part of this study is called obeticholic acid. Obeticholic acid is already licenced for the treatment of PBC in people who have not responded to urso, and it has a well-known safety profile.
People who meet trial criteria and want to take part will be treated with either OCA or placebo ("dummy drug"), in addition to urso (the current standard care) for up to 6 months. After this time point, people will be followed up as part of the trial for an additional 6 months thereafter.
The trial will recruit at hospitals across the UK, and aims to recruit 106 people with PBC.REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0878
Date of REC Opinion
31 May 2023
REC opinion
Further Information Favourable Opinion