DIALIVE 2.0 in ACLF
Research type
Research Study
Full title
A multi-centre, randomised controlled trial to evaluate the efficacy of DIALIVE 2.0, a liver dialysis device, for the treatment of acute on-chronic liver failure (ACLF) ATANGO grade 2-4 compared to standard of care (SoC)
IRAS ID
353362
Contact name
Carrie Morgan
Contact email
Sponsor organisation
Yaqrit Ltd
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
This study aims to find out whether a new treatment called DIALIVE 2.0 can help people with acute-on-chronic liver failure (ACLF) recover better compared to the current standard medical treatment. Acute-on-chronic liver failure (ACLF) is a serious condition that occurs when someone with long-term liver disease suddenly experiences a rapid worsening of liver function, which can lead to multiple organ failure.
The study will take place in around 12 UK hospitals. A total of 72 participants will take part. Each participant will be randomly placed into one of two groups in ratio 1:1. We will use stratified randomisation with 60% of participants presenting with A-TANGO ACLF grade 2 and 40% with grades 3 or 4 in each treatment arm. One group which is control group will receive the standard medical care that doctors normally provide for acute-on-chronic liver failure (ACLF) patients. The other group which is DIALIVE 2.0 treatment group will receive the same standard medical care plus up to seven sessions of DIALIVE 2.0 treatment over a period of 10 days.
DIALIVE 2.0 is a special device-based treatment designed to help remove harmful substances from the blood and support the body’s natural healing process while the liver recovers.
Participants will take part in the study for up to 105 days in total. This includes up to 5 days for screening, up to 10 days of treatment, and a follow-up period of 90 days to monitor recovery and safety.
The study will last about 18 months in total, from the first participant being screened until the last participant finishes follow-up.
REC name
London - South East Research Ethics Committee
REC reference
26/LO/0090
Date of REC Opinion
4 Mar 2026
REC opinion
Further Information Favourable Opinion