RecruitingPhase IIInterventional

The use of CARBALIVE in the treatment of cholestatic liver disease

This study is looking for people in the UK who have primary sclerosing cholangitis (PSC), a liver condition, and inflammatory bowel disease. In PSC, harmful gut bacteria can leak into the liver and cause damage over time. This trial will test a new medicine called CARBALIVE (also known as Yaq-001). CARBALIVE is designed to soak up these harmful bacterial bits in the gut, stopping them from reaching the liver. Researchers want to find out if CARBALIVE is safe and well-tolerated, and if it helps improve the overall health of people with PSC. The study involves taking CARBALIVE for 12 weeks and attending regular check-ups.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Yaqrit Limited

Enrolment target

Start

13 Oct 2025

Estimated completion

13 Aug 2026

The study is looking at patients with primary sclerosing cholangitis and co-existant inflammatory bowel disease.

What is this study about?

Imagine your gut has lots of tiny living things called bacteria. Usually, these bacteria stay safely in your gut. But for people with a liver condition called primary sclerosing cholangitis (PSC), the types of bacteria in their gut are different. Sometimes, parts of these gut bacteria can leak out and travel to the liver. When this happens, it can cause swelling and damage in the liver, leading to scarring over time. This continuous damage can eventually stop the liver from working properly, which might then require a liver transplant.

This study is testing a new treatment called CARBALIVE (or Yaq-001). CARBALIVE is a special type of carbon that works like a sponge. It's designed to stick to these leaked bacterial bits in your gut, preventing them from travelling to your liver. Once the CARBALIVE has soaked up these harmful bits, your body gets rid of them naturally when you go to the toilet. This means CARBALIVE itself doesn't get absorbed into your bloodstream.

Researchers have previously seen good results with CARBALIVE in animal studies and in people with advanced liver disease from other causes. The main goal of this particular trial is to see if CARBALIVE works in the same way for people who have PSC. They want to check if it's safe to use, if people tolerate it well, and if it helps to make them feel better overall. By understanding how CARBALIVE affects people with PSC, we can learn more about how to treat this condition.

Key takeaways

Tests a new treatment, CARBALIVE, for primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD).
Aims to stop harmful gut bacteria from leaking to the liver and causing damage.
Involves taking CARBALIVE by mouth for 12 weeks.
Requires regular hospital visits (at weeks 1, 6, and 12) for health checks and samples.
Your participation will help improve understanding and treatment for PSC.
Recruitment starts October 2025.

Who may be eligible?

This study is specifically looking for 12 patients who have both primary sclerosing cholangitis (PSC), a liver condition, and inflammatory bowel disease (IBD). To be considered, your liver should show signs of moderate to advanced scarring, which can be checked through various tests.

You would need to be 16 years old or older and be able to understand and follow the study instructions. If you are taking medicines for your IBD, like biologics or other strong medications, you must have been on a steady dose for at least 12 weeks before starting the study and expect to stay on that dose throughout.

However, you wouldn't be able to join if your liver disease is caused by other specific conditions, or if you have certain other liver problems. The study team will review your medical history carefully to make sure the study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Do you have a confirmed diagnosis of primary sclerosing cholangitis (PSC)?
Do you also have a confirmed diagnosis of inflammatory bowel disease (IBD)?
Do tests show you have moderate to advanced scarring in your liver?
If you take medication for your IBD, have you been on a steady dose for at least 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part and your initial information suggests you might be suitable, you’ll first have a screening visit. At this visit, you'll read and sign a consent form, then the team will check your medical history, current medications, do a physical exam, take your blood pressure, pulse, breathing rate, and temperature. You'll also provide blood, stool, and urine samples.

Once the results confirm you can join, you’ll start treatment. The first six participants will take 8 grams of CARBALIVE each day, and the next six will take 12 grams daily to check the safety of different doses. You'll take CARBALIVE in sachets by mouth for 12 weeks.

During these 12 weeks, you'll have study visits at week 1 (when you start treatment), week 6, and week 12. Each visit will involve another physical exam, checking your vital signs, giving blood and urine samples, and discussing any changes in your health or medications. You'll also fill out a questionnaire about your health and wellbeing. These visits are expected to last about an hour. You can provide a stool sample at home up to 24 hours before each visit. After the final visit at week 12, your participation in the study will be complete.

Potential risks and benefits

Taking part in this study is completely your choice. While there might not be a direct personal benefit for you, your involvement will be very valuable. It helps researchers learn more about PSC and understand if CARBALIVE could be a future treatment option for others with the condition. As with any medical study, there are some small risks. These include discomfort, temporary dizziness, or bruising from blood tests. There's also a chance of side effects from CARBALIVE, like feeling sick (nausea), being sick (vomiting), constipation, or diarrhoea, though these are expected to be uncommon (less than 5%). If these occur, the study doctor can prescribe medicine to help. CARBALIVE might also affect how other medicines work, so the team will tell you when to take your other medications. There's a slight possibility your vitamin levels could drop, but the team will monitor this with blood tests and provide supplements if needed. It's important to remember there could be other unknown side effects, and you can discuss any concerns with the research team. You are free to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, United Kingdom

Common questions

What is primary sclerosing cholangitis (PSC)?

PSC is a long-term liver condition where the bile ducts inside and outside the liver become inflamed and scarred, eventually blocking the flow of bile.

What is CARBALIVE?

CARBALIVE (Yaq-001) is a new medicine made of a special carbon that acts like a sponge, soaking up harmful bacterial fragments in the gut to stop them from reaching the liver.

How long will I take the treatment?

You will take the CARBALIVE treatment for 12 weeks.

Where is the study taking place?

The study is being run from The Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, in the UK.

Who is funding this research?

The study is funded by LifeArc Ltd.

How to find out more

Palak Trivedi

p.j.trivedi@bham.ac.uk +44 (0)1213718173 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.