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Acute-on-Chronic Liver Failure (ACLF)NCT07347275

A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.

A study of Acute-on-Chronic Liver Failure (ACLF) and Liver Cirrhosis, run by Yaqrit Ltd at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-70 years, with a diagnosis of ACLF grade 2-4 (according to A-TANGO ACLF criteria, APPENDIX 1)
  • ACLF non-responsive to SoC for up to 48 hours prior to developing grade 2-4 ACLF.
  • Inclusion within 10 days from the onset of A-TANGO ACLF grade ≥ 2.

Who cannot join

  • A-TANGO ACLF grade ≥2 for more than 10 days prior to inclusion
  • Pregnancy
  • Co-infection with HIV and AIDS defining illness i.e. CD4+ T-cell count below 200 cells/µL, a CD4+ T-cell percentage of total lymphocytes of less than 15%, or one of the defining illnesses such as PCP, Kaposi's sarcoma, CMV, Candidiasis etc.
  • Bacterial infection or sepsis unresponsive to treatment with antimicrobials for 48 hours indicated by (a) persistent pyrexia (b) rising white cell count, creactive protein and lactate (c) persistently positive cultures for bacteria or fungi and/or (d) worsening clinical state indicated by escalating requirement for fluid resuscitation, increasing vasopressors requirements or increasing organ support.
  • Invasive fungal infection (clinical or radiological evidence, not solely biomarker positivity such as BDG or galactomannan)
  • Acute or sub-acute liver failure in the absence of cirrhosis
Show all 33Show fewer
  • Post-hepatectomy liver failure or primary non-function following transplantation
  • Previous liver transplant
  • Severe thrombocytopaenia (absolute platelet count <20,000/mm3 at screening) or evidence of rapid decline in platelet count (> 50% reduction within the preceding 24 hrs)
  • INR >3.0, unless sustained correction for >24 hours following FFP/PCC treatment
  • Severe disseminated intravascular coagulopathy (DIC)
  • Persistent haemodynamic instability as defined by:
  • 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
  • Severe respiratory failure: PaO2/FiO2 (P/F) ≤ 200 mmHg or 27kPa
  • Established on renal replacement therapy for longer than 24 hours prior to inclusion
  • A-TANGO WCC ACLF score >64 (APPENDIX 1)
  • Significant and/or uncontrolled bleeding (participants can be enrolled 48 hours after bleeding is controlled)
  • Active or prior history of non hepatic malignancy unless adequately treated or in complete remission for five or more years
  • HCC outside of Milan criteria.
  • Acute, extensive, portal vein thrombosis extending to and occluding superior mesenteric vein
  • Major systemic illness, aside from liver disease, that in the opinion of the investigator would preclude the participant from participating in the study (e.g. coronary artery disease, cerebrovascular disease, chronic pulmonary disease, chronic kidney disease, serious psychiatric disease)
  • Pre-existing chronic kidney disease (CKD) defined as eGFR (estimated glomerular filtration rate) <30 mL/min for 3 months or longer prior to screening
  • Severe frailty (Clinical Frailty Scale, CFS>5)
  • Severe malnourishment (BMI<18)
  • Participants not considered appropriate for full active treatment including organ support
  • Participants who have a "do not attempt cardio-pulmonary resuscitation" order in place
  • Any participant who has received an investigational drug or device within 30 days, or who is scheduled to receive another investigational drug or device during the course of the study (concomitant observational studies are allowed)
  • Uncontrolled seizures
  • Evidence of new intracranial pathology such as cerebral hemorrhage or infarction.
  • Participants diagnosed with Creutzfeldt-Jakob disease.
  • Participants unable to consent for themselves, unless a legal representative/consultee is appointed and approved as dictated by local and national legislation.
  • Known allergy to heparin, or type II thrombocytopaenia caused by heparin (HIT syndrome type II).
  • In the opinion of the investigator, recruitment to the the study would be unsafe for the participant.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Royal Free Hospital

    London, Greater London, NW3 2QG

    Christine Eastgate, +442077940500 ext. 39603, christine.eastgate@nhs.net

    Abigail Brownlie, MSc, +442077940500 ext. 22522, abigail.brownlie@nhs.net

    Recruiting

Other trials in United Kingdom

About this study

Official 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) A-TANGO Grade 2-4 Compared to Standard of Care (SoC)

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.

Read the detailed description

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:

  • Medica FRACTIOsmart Small 1.0 haemodialyser with a high cut-off membrane (150 to 200 kilodaltons), used for the removal of albumin-bound toxins and medium-sized inflammatory molecules. This component is commercially available under European certification MDR 00048-A.
  • Alteco® Medical LPS Adsorber, an extracorporeal filter designed for the selective removal of circulating endotoxin in conditions where endotoxemia is suspected or confirmed. This is a commercially available device certified under CE 0402, (awaiting MHRA registration).
  • Medica AFERsmart Plus™ System, a plasmapheresis platform that controls flow rates, treatment duration, and pressure regulation. This is commercially available, and CE marked under number 0476.
  • Medica AFERsmart Standard TPE Line, a sterile, CE-marked disposable tubing set compatible with the AFERsmart Plus device.
  • Male to male tubing set, and absorber connector, (pending commercial approval).
Being tested
Standard of Care (Investigator Choice), DIALIVE 2.0 liver dialysis Device plus available Standard of Care
Medical subject headings
Acute-On-Chronic Liver Failure, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care (Investigator Choice)Other

    Standard of care as per Investigator discretion

  • DIALIVE 2.0 liver dialysis Device plus available Standard of CareDevice

    DIALIVE 2.0 liver dialysis Device plus available Standard of Care

Study groups in NCT07347275
Study groupRoleWhat they receive
Control groupOtherStandard of Care (Investigator Choice)
Receives: Other: Standard of Care (Investigator Choice)
Treatment GroupExperimentalDIALIVE 2.0 liver dialysis Device plus available Standard of Care (Investigator Choice)
Receives: Other: Standard of Care (Investigator Choice); Device: DIALIVE 2.0 liver dialysis Device plus available Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Baseline to within 10 Days

Secondary outcomes (6)
  1. 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.

    Measured: From enrollment through Day 90 for each participant (assessed at Day 28 and Day 90)

  2. 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).

    Measured: From baseline through Day 90 for each participant (assessed at Day 28 and Day 90)

  3. 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.

    Measured: Predicted at baseline using data collected through Day 28 for each participant

  4. 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.

    Measured: From baseline until discharge from ICU and/or hospital, assessed up to Day 28 for each participant

  5. 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.

    Measured: From baseline through Day 28 for each participant

  6. 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.

    Measured: From baseline through Day 10 for each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Seventy-two evaluable participants will be randomised 1:1 to receive either Standard of care (SoC) or Standard of care (SoC) + DIALIVE 2.0. We will use stratified randomisation with 60% of participants presenting with A-TANGO Acute-on-Chronic Liver Failure (ACLF) grade 2 and 40% with grades 3 or 4 in each treatment arm.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07347275
Sponsor's protocol ID
YAQ002-ES-1
Other IDs
206537, CI/2025/0075/GB, 353362
Status last verified
Sep 2026
First submitted
11 Dec 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be made available on reasonable request.

Questions about this trial

What is this clinical trial studying?

A study of Acute-on-Chronic Liver Failure (ACLF) and Liver Cirrhosis, run by Yaqrit Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carrie Morgan (+44 (0) 7970771628, carrie.morgan@yaqrit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the proportion of participants with resolution of ACLF following DIALIVE 2.0 treatmen (time frame: From Baseline to within 10 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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