CATCH Trial (V0.4)
Research type
Research Study
Full title
An open-label trial of CARBALIVE for the Treatment of Cholestatic Liver Disease
IRAS ID
347693
Contact name
Palak Trivedi
Contact email
Sponsor organisation
Yaqrit Ltd
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
Primary sclerosing cholangitis (PSC) is a disease that causes inflammation and scarring of the bile ducts. At present there are no medicines that have been shown to slow down the rate of liver damage, and liver transplantation is the only life-saving treatment for people living with the disease.
This study is a phase IIa, single-centre, open-label, sequential cohort dosing clinical trial. It aims to determine the safety and tolerability of two doses (8g and 12g) of once daily, orally administered Yaq-001 (henceforth known as CARBALIVE) over 12 weeks, in patients with primary sclerosing cholangitis, who have moderate-advanced fibrosis and compensated liver disease.
CARBALIVE is an engineered carbon with defined pore sizes critical to its functionality in binding and removal of endotoxin and inflammatory molecules. CARBALIVE is not absorbed through the wall of the alimentary tract into the body. Its mechanism of action is mechanical in nature; it physically binds bacterial metabolites and toxins within the intestinal tract. There does not appear to be a direct pharmacological, immunological or metabolic effect, given that CARBALIVE is not systemically adsorbed, but its effects may be due to its binding and removal of inflammatory molecules and endotoxins.
Based on pre-clinical data, the potential clinical benefits for cholestatic and cirrhotic subjects are an improvement in organ function, a reduction in blood endotoxin activity, and an improvement in clinical status. This investigation aims to confirm the safety and tolerability of daily 8g and 12g doses of CARBALIVE and evaluate potential efficacy based on disease related biomarkers to help inform potential pivotal efficacy evaluation of CARBALIVE as a treatment for PSC in later studies.
Preliminary clinical data on exploratory biomarkers of liver disease in stable decompensated cirrhotic patients indicate a potential benefit of reduced systemic and gut inflammation, and reduced endotoxins. These data drive the hypothesis that CARBALIVE could reduce PSC disease status and, if cirrhosis develops, reduce hepatic decompensation events.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0051
Date of REC Opinion
17 Jun 2025
REC opinion
Further Information Favourable Opinion