RESUS Study
Research type
Research Study
Full title
REpurposing SirolimUS in compensated advanced chronic liver disease. The RESUS proof of concept study
IRAS ID
278111
Contact name
Aloysious Aravinthan
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Eudract number
2021-004946-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Background: Advanced liver scarring leads to liver failure, liver cancer and premature death. It mainly affects people in the working age group (18-65 years) and is the only major cause of death that is still increasing every year in the UK. It costs the NHS £2.1 billion a year. This will continue to rise due to increasing alcohol misuse and the obesity crisis. Advanced liver scarring remains incurable as there is no treatment to slow progression of scarring. Sirolimus is a medication that has been used to prevent rejection after organ transplantation for over 20 years. It reduces liver scarring, improves liver functioning and prolongs life in animals. It has also been shown to reduce liver scarring in patients after liver transplantation. Sirolimus, therefore offers a potential treatment option for liver scarring.
Question and Objectives: If used in patients with advanced liver scarring, can sirolimus slow the progression of scarring? Our main objective is to undertake a small-scale study (proof of concept) to investigate if sirolimus could slow the progression of scarring in patients with advanced liver scarring using clinically relevant biomarkers, which will see if the liver responds to treatment.
How it will be done: The study will be conducted in Nottingham University Hospitals NHS Trust. 45 patients with advanced liver scarring will be randomly given either sirolimus or placebo tablets daily for 6 months. Participants will have a liver biopsy and a MRI scan at the start and end of the study to measure the change in the biomarkers of liver scarring. A reduction in these markers will indicate successful treatment. Participants will be monitored for safety of the drug.
Potential Impact: If found efficacious, sirolimus would provide an acceptable treatment for patients with advanced liver scarring and would also save a substantial sum of money for the NHS.
REC name
Wales REC 5
REC reference
21/WA/0328
Date of REC Opinion
24 Nov 2021
REC opinion
Further Information Favourable Opinion