A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYaqrit Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care (Investigator Choice)
Other interventionStandard of care as per Investigator discretion
DIALIVE 2.0 liver dialysis Device plus available Standard of Care
DeviceDIALIVE 2.0 liver dialysis Device plus available Standard of Care
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Control groupOther 1 intervention
Group B: Treatment GroupExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
From Baseline to within 10 DaysSecondary outcomes
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.
Time frame
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).
Time frame
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.
Time frame
Predicted at baseline using data collected through Day 28 for each participant4
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 participantSponsors and contacts
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Yaqrit Ltd
Lead sponsor
University College, London
Collaborator
King's College Hospital NHS Trust
Collaborator
University Hospital Birmingham NHS Foundation Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov