Observational study in patients with liver cirrhosis
Research type
Research Study
Full title
A Multicentre, Observational Study in Patients with Liver Cirrhosis who have been Hospitalised for the First Time for Hepatic Decompensation (OPAL)
IRAS ID
329101
Contact name
Jonathan Fallowfield
Contact email
Sponsor organisation
Resolution Therapeutics Ltd
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
The aim of this observational study is to follow the disease progression of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital for the first time or required them to seek medical attention as an outpatient.
Typical clinical features of a hepatic decompensation event include yellowing of the skin, mucous membranes, and whites of the eyes (jaundice), ascites (the build-up of fluid in the space between the lining of the abdomen and abdominal organs), reversible syndrome of impaired brain function occurring with advanced liver diseases (hepatic encephalopathy), conditions arising from acute kidney injury associated with advanced liver disease (hepato-renal syndrome) or bleeding from enlarged veins found throughout the gastrointestinal tract, oesophagus, stomach, and rectum (variceal haemorrhage).
This study is an observational study only, and the study data will primarily be collected through a review of the participants medical records at specified timepoints. The study does not involve the administration of any study medication, additional medical tests, or changes to normal standard of care treatment. However, at specified timepoints, we will collect a blood sample to look at molecules in the blood that can help to inform about how the liver is functioning. This may require up to 5 additional study specific visit(s).
Overall, this study will enable us to better understand what happens to patients after a first 'decompensation event', to identify which patients most need treatment, and how we should measure success.
REC name
Wales REC 7
REC reference
23/WA/0192
Date of REC Opinion
7 Jul 2023
REC opinion
Further Information Favourable Opinion