REpurposing SirolimUS in Compensated Advanced Chronic Liver Disease. The RESUS Proof of Concept Study (RESUS)
Advanced Chronic Liver Disease
About this trial
This is an interventional treatment trial for Advanced Chronic Liver Disease focused on measuring mTOR, liver fibrosis
Eligibility Criteria
Inclusion Criteria: capable of giving informed consent aged 18-70 years compensated advanced chronic liver disease (Child Pugh class A) due to excess alcohol consumption or fatty liver disease willing to and able to undergo percutaneous or endoscopic ultrasound-guided liver biopsy at baseline and at 6 months Exclusion Criteria: inability to provide informed consent inability to comply with the study protocol subjects who may be unavailable for the duration of the treatment course, likely to be noncompliant, or who are felt to be unsuitable by the Investigator for any other reason previous history of decompensation of liver disease or liver cancer women who are pregnant or breastfeeding unable or unwilling to use highly effective contraception during and 12 weeks after the trial participation history of allergy or adverse event to sirolimus previous or current use of sirolimus concurrent use of experimental agents an unstable or uncontrolled medical disorder which in the investigator's opinion precludes recruitment within the trial major medical comorbidities (e.g., end-stage organ disease, cancer or immunodeficiency) increased risk of infectious complications (e.g., immunodeficiency, recent live vaccination) surgery within the past 6 months or an anticipated requirement for surgery during the study period
Sites / Locations
- Queen's Medical Centre, Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Sirolimus
15 participants will receive a non-identical placebo tablet. They will be asked to take the placebo daily, exactly as instructed for the intervention arm, be subject to monitoring and random titration to mirror the study drug
30 participants will be randomised to the study drug.