Case study: liver dialysis device, DIALIVE, proves safe and effective - Clinical Trial Services, UK

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PHARMExcel announces publication of its report in the Journal of Hepatology.

Now available online >

Journal of Hepatology: Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure

As the UK CRO supporting the pan-European DIALIVE study, PHARMExcel is delighted to announce that together with researchers from UCL, the Royal Free Hospital, UCL spin-out Yaqrit, and their collaborators, it has successfully completed the first in-patient trial of liver dialysis. The trial involved the use of a device called DIALIVE, invented by researchers at UCL’s Institute for Liver and Digestive Health. The device was found to be safe and led to substantial improvement in symptoms and organ function in a great proportion of patients with acute-on-chronic liver failure (ACLF) compared to standard of care. The next step is to conduct a larger clinical trial, and if successful, DIALIVE could be approved for clinical use within the next three years.

ACLF is a condition that causes a sudden decline in liver function, posing a high risk of short-term death. Globally, there are around 100 million people living with cirrhosis of the liver, with about 10 million having cirrhosis along with an additional complication. The UK alone sees approximately 15,000 ACLF patients each year, and their treatment costs the NHS around £100,000 per patient without improving mortality risk.

The liver performs numerous vital functions, including the removal of harmful substances from the blood and the production of albumin, a protein that helps absorb unwanted substances in the body. In ACLF, liver function is seriously impaired, leading to liver cell death and bacterial leakage from the gut into the bloodstream. DIALIVE was designed to address these mechanisms that contribute to mortality in ACLF patients.

The trial involved 32 patients who received treatment with DIALIVE or standard of care for up to five days. The results showed that DIALIVE treatment led to a significantly faster reversal of ACLF compared to standard of care, with ACLF resolving in about twice the number of patients. DIALIVE treatment also resulted in a reduction in endotoxins and improved albumin function. Biomarkers of systemic inflammation and markers of cell death also showed improvement. Patients whose ACLF resolved after receiving as little as three days of DIALIVE treatment remained in remission for 28 days.

The next phase will involve a larger trial to further confirm the safety and effectiveness of DIALIVE, including its impact on patient mortality compared to other available care.

DIALIVE was invented by Professor Rajiv Jalan and Professor Nathan Davies at UCL’s Institute for Liver and Digestive Health. The technology behind the device was patented by UCL in 2009 and licensed to the spin-out company Yaqrit. The research was funded by the European Union’s Horizon 2020 program.

Professor Rajiv Jalan (UCL Medicine), inventor of DIALIVE and co-founder of Yaqrit, said: “As academics it can be difficult to define a disease then translate this knowledge into a clinical solution that makes a real difference to people’s lives. So, the results of the DIALIVE trial are an emotional moment, which wouldn’t have been possible without scientific collaboration between the UK, European colleagues, and funding from the European Commission. My hope is that within a few years we will start to fulfil the urgent unmet need for treating acute-on-chronic liver failure and improve outcomes for patients.”

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About PHARMExcel

PHARMExcel is an award-winning, full-service Contract Research Organisation (CRO) providing a flexible and innovative approach to clinical trial delivery. The company is recognised for its in-depth knowledge and experience of the clinical research environment, particularly in the UK, and has a network of regulatory and industry associates, allowing it to provide a global reach.

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