Vital Therapies Inc, (VTI) is pleased to announce that the first two subjects have been enrolled at King’s College Hospital in London in the expansion of its SILVER (Stabilisation In LiVER failure) clinical trial in Europe.
The trial is evaluating whether VTI’s biological cellular therapy product, ELAD, can prevent deterioration of liver function and improve the survival of patients with acute-on-chronic liver failure (ACLF).
The SILVER trial is an open label, multi centre, controlled, randomised trial. To date, 29 subjects have been enrolled at 11 US sites and one UK site at King’s College Hospital, a major European centre for the treatment of complex liver disease.
The SILVER protocol enrolls subjects with chronic liver disease who have been hospitalised as a result of an event, such as an infection or an episode of bleeding, which has caused deterioration of their liver function (acute-on-chronic liver failure, ACLF).
The trial is designed to explore whether the use of ELAD in this setting can prevent continued deterioration of liver function, called progression, and thus improve survival.
The trial design uses a well-established measure of liver function called the MELD score to define the status of liver function. Treatment with ELAD, along with standard of care, is compared with standard of care alone.
The time to either death or deterioration of liver function by a prespecified amount is measured. It is postulated that the use of ELAD may extend the time to progression and improve survival in this rapidly progressing patient population.
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