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

NCT07347275 | Not Yet Recruiting Phase 3 DMC

• 4 other identifiers: YAQ002-ES-1206537CI/2025/0075/GB353362
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Liver Cirrhosis; Acute-on-Chronic Liver Failure (ACLF)

Outcome Measures

Primary Outcomes (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.

  From Baseline to within 10 Days

Secondary Outcomes (6)

• Transplant-free survival following DIALIVE 2.0 treatment plus standard of care compared with standard of care alone

  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

  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

  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

  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

  From baseline through Day 28 for each participant

Study Arms (2)

Control group

OTHER

Standard of Care (Investigator Choice)

Other: Standard of Care (Investigator Choice)

Treatment Group

EXPERIMENTAL

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

Interventions

Standard of Care (Investigator Choice) OTHER

Standard of care as per Investigator discretion

Control group; Treatment Group

DIALIVE 2.0 liver dialysis Device plus available Standard of Care DEVICE

DIALIVE 2.0 liver dialysis Device plus available Standard of Care

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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:
• (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
• Severe respiratory failure: PaO2/FiO2 (P/F) ≤ 200 mmHg or 27kPa
• A-TANGO WCC ACLF score \>64 (APPENDIX 1)
• Significant and/or uncontrolled bleeding (participants can be enrolled 48 hours after bleeding is controlled)

Sponsors & Collaborators

• Yaqrit Ltd: lead
• University College, London: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Cirrhosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Carrie Morgan

CONTACT

+44 (0) 7970771628; carrie.morgan@yaqrit.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04