CATCh Clinical Trial
Is CARBALIVE safe for people with PSC?
Recruiting now
What is Carbalive?
In PSC, the make up of the gut microorganisms is different to those without liver and bowel inflammation. This has been implicated in driving inflammation through the production of harmful substances called endotoxins that pass from the gut to the liver.
The CARBALIVE device has been shown to bind endotoxins and other harmful substances in the gut, and reduce the passage of these substance to the liver. It then passes into your stool when you have a bowel movement, without any of it being absorbed by your body. It is believed that this will help maintain (and possibly improve) your level of liver function – this has been shown in other liver diseases.
If you decide to take part in the CATCh trial, you would be helping us understand whether CARBALIVE is safe for people with PSC, and potentially effective in maintaining (or improving) liver function.
| Trial Name | CATCh
An open-label trial of CARBALIVE for the Treatment of Cholestatic Liver Disease |
| UK Clinical Study Registry number | ISRCTN16819837 |
| Phase | Phase 2a Trial |
| Intervention | CARBALIVE: carbon beads ingested orally which are capable of binding toxins in the gut.
Dose of 8g or 12g once a day. |
| Recruiting now? | Estimated recruitment start date 18th September 2025 |
| Participating Centres | Queen Elizabeth Hospital, Birmingham |
| Liver disease diagnosis | Primary sclerosing cholangitis (PSC) |
| Age | 16 and over |
| Females: can I be pregnant? | No |
| Is IBD (inflammatory bowel disease) allowed? | Yes - this is required for inclusion in the study |
| Is there an ALP (alkaline phosphatase) requirement? | ALP values above the upper limit of normal |
| Can I take UDCA (Urso)? | Yes, if on a stable dose of UDCA for at least 12 weeks prior to screening |
| Can I take biologics? | Yes, if on a stable dose for IBD for at least 12 weeks prior to screening |
| Can I take part if I have a stent? | No |
| Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed? | No acute cholangitis attacks allowed for 12 weeks prior to screening |
| Can I take part if I have had a liver transplant? | No |
| Is cirrhosis allowed? | Yes, this study targets patients with moderate-advanced fibrosis up to very early cirrhosis. |
| Previous studies and information | Liu J, MacNaughtan J, Kerbert AJC, et al. Clinical, experimental and pathophysiological effects of Yaq-001: a non-absorbable, gut-restricted adsorbent in models and patients with cirrhosis Gut 2024;73:1183-1198. |
| Are travel expenses covered? | Reasonable travel expenses covered (up to a maximum of £30 per treatment visit). |
| Procedures and tests include: | Blood tests, stool tests, urine tests, health reviews, pregnancy test (women), Fibroscan, and health-related quality of life questionnaires. |
| How many study visits will there be? How long will each study visit be? | There is one hospital visit to check you are eligible to take part in the trial, then three hospital appointments for the treatments.
More detailed information is available in the Participant Information Sheet. |
| Duration of study (treatment duration/follow-up) | Screening period: 2 weeks Duration of treatment: 12 weeks Total duration of study: 14 weeks |
| Basic design of study | A Phase IIa, single-centre, open-label, sequential cohort dosing clinical trial. |
| Link to Patient Information (or pdf) How is this intervention thought to work and what is it thought to do? Or patient area on trial website etc |
The CARBALIVE device has been shown to bind (stick to) endotoxins and other harmful substances in the gut and reduce the passage of these substances to the liver. It then passes into your stool when you have a bowel movement, without any of it being absorbed by your body. It is believed that this will help maintain (and possibly improve) your level of liver function – this has been shown in other liver diseases.
More detailed information is available in the Participant Information Sheet. |
| Study website | Not available |
| Link to sponsor | Yaqrit Ltd. |
If you're interested in taking part, please email CATChtrial@uhb.nhs.uk