ClinicaliQ Trial Snapshot
- A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device. — Recruiting • Non-phase study • Gastroenterology • NCT07347275.
- What is being tested: The DIALIVE 2.0 liver dialysis device, an extracorporeal liver support system designed to be used alongside standard care in patients with acute-on-chronic liver failure (ACLF), specifically grades 2-4 severity.
- Patient eligibility overview: Adults aged 18-70 years with acute alcoholic liver disease presenting with ACLF grade 2-4 (A-TANGO classification), with approximately 72 evaluable participants required for the study.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.