An interventional study of Standard of Care (Investigator Choice) and DIALIVE 2.0 liver dialysis Device plus available Standard of Care in Acute-on-Chronic Liver Failure (ACLF) and Liver Cirrhosis, sponsored by Yaqrit Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Yaqrit Ltd · Not applicable, Interventional, and Treatment
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4.
A total of 72 evaluable participants, aged 18-70, will be enrolled in up to 12 clinical centres in the United Kingdom. Participants must have a history of liver cirrhosis and a deterioration within four weeks due to a precipitating event, leading to A-TANGO ACLF grade 2-4. Multicenter, individually randomised, controlled, open-label, parallel group trial using double-arm design. The control group will receive SoC for participants with ACLF. The DIALIVE 2.0 treatment group will receive SoC with the addition of up to 7 (seven) daily DIALIVE 2.0 treatment sessions within the 10-day treatment window. Seventy-two participants with ACLF (60% A-TANGO ACLF grade 2 at randomisation, and 40% A-TANGO ACLF grade 3 \& 4 at randomisation) will be randomised 1:1 to receive either SoC or SoC + DIALIVE 2.0. This allows for 5% loss due to drop-out, and 5% censoring due to liver transplantation within 28 days. All randomised participants will be included in the intention to treat (ITT) analysis while all participants that receive at least one treatment cycle will be used for the safety population. For each participant, the study duration will be up to 105 days (screening: 5 days; treatment up to 10 days; follow up 90 days).
The total study duration is estimated to be approximately 18 months from screening of first participant until study completion of the last participant.
DIALIVE 2.0 is an innovative liver dialysis device that specifically targets the underlying mechanisms of acute-on-chronic liver failure.
The novelty of DIALIVE 2.0 lies in the combined use of a commercially available high cutoff filter and an extracorporeal endotoxin adsorber integrated into a hemofiltration and plasmapheresis platform. This allows controlled extracorporeal circulation of the participant's blood, during which the system removes dysfunctional, toxin-bound albumin and circulating endotoxins, while simultaneously replenishing functional albumin. The result is a comprehensive therapeutic approach that addresses both immune dysregulation and impaired albumin detoxification capacity in acute-on-chronic liver failure. This treatment concept is referred to as Selective Plasma filtration, Endotoxin Adsorption, and Albumin Replacement (SPEAR), reflecting the three core processes that underpin DIALIVE 2.0's mode of action.
DIALIVE 2.0 is delivered as a daily treatment lasting six to eight hours, with a plasma filtration dose equivalent to 5% of the participant's ideal body weight. Albumin is replaced at a dose of one gram per kilogram of body weight using a 20% human albumin solution to offset albumin losses and maintain oncotic pressure. To address coagulation factor depletion observed in preclinical studies (see Investigators Brochure), one unit of fresh frozen plasma is administered at the end of each session to restore haemostatic balance.
The DIALIVE 2.0 system includes the following components:
165 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 60 are open to participants now.
This study's planned enrollment of 72 is close to the median of 72 across 95 interventional studies indexed under Acute-On-Chronic Liver Failure.
Browse Acute-On-Chronic Liver Failure studies →Yaqrit Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Persistent haemodynamic instability as defined by:
(i) Norepinephrine(NE) dose >0.5µg/kg/min, or, (ii) If a second pressor is used, a composite Norepinephrine equivalence index (NEEI) of dose >0.5µg/kg/min (iii) Arterial lactate level >4mmol/L despite 24 hours of adequate fluid resuscitation and pressor therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of Care (Investigator Choice)
Other: Standard of Care (Investigator Choice)
DIALIVE 2.0 liver dialysis Device plus available Standard of Care (Investigator Choice)
Other: Standard of Care (Investigator Choice) · Device: DIALIVE 2.0 liver dialysis Device plus available Standard of Care
Standard of care as per Investigator discretion
DIALIVE 2.0 liver dialysis Device plus available Standard of Care
Change in the proportion of participants with resolution of ACLF following DIALIVE 2.0 treatmen
Assessment of the change in the proportion of participants achieving resolution of ACLF following treatment with DIALIVE 2.0 plus standard of care (SoC) within 10 days of treatment.
Time frame: From Baseline to within 10 Days
Transplant-free survival following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone
Assessment of transplant-free survival in participants treated with DIALIVE 2.0 plus standard of care (SoC) compared with participants treated with SoC alone.
Time frame: From enrollment through Day 90 for each participant (assessed at Day 28 and Day 90)
Incidence of serious adverse events (SAEs) following DIALIVE 2.0 treatment
Assessment of the incidence of treatment-emergent serious adverse events in participants receiving DIALIVE 2.0 plus standard of care (SoC).
Time frame: From baseline through Day 90 for each participant (assessed at Day 28 and Day 90)
Predicted six-month and one-year survival following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone
Assessment of predicted six-month and one-year survival rates in participants treated with DIALIVE 2.0 plus standard of care (SoC) compared with participants treated with SoC alone.
Time frame: Predicted at baseline using data collected through Day 28 for each participant
Time to discharge from ICU and/or hospital following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone
Assessment of time to discharge from the intensive care unit (ICU) and/or hospital in participants treated with DIALIVE 2.0 plus standard of care (SoC) compared with participants treated with SoC alone.
Time frame: From baseline until discharge from ICU and/or hospital, assessed up to Day 28 for each participant
Resolution of individual organ failures following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone
Assessment of the proportion of participants with resolution of individual organ failures in participants treated with DIALIVE 2.0 plus standard of care (SoC) compared with participants treated with SoC alone.
Time frame: From baseline through Day 28 for each participant
Resolution of A-TANGO ACLF grade 2-4 following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone
Assessment of resolution from A-TANGO ACLF grade 2-4 to absence of ACLF in participants treated with DIALIVE 2.0 plus standard of care (SoC) compared with participants treated with SoC alone.
Time frame: From baseline through Day 10 for each participant
Plan to share: Yes — De-identified individual participant data will be made available on reasonable request.
Access criteria: Available to qualified researchers for approved research purposes.
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Acute-On-Chronic Liver Failure →
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