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New liver dialysis machine could save lives in severe liver failure

NCT ID NCT07347275

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called DIALIVE 2.0, which acts like a dialysis machine for the liver, in people with severe acute-on-chronic liver failure (ACLF). The goal is to see if adding up to 7 daily treatments to standard care helps more patients recover from liver failure and survive without needing a liver transplant. The trial will include 72 adults aged 18-70 with advanced ACLF across UK hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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 * 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.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.