NCT03065699: DIALIVE _ACLF

Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients

Completed NA Last updated 1 June 2021

What this trial tests

NA trial testing DIALIVE Liver Dialysis Device in Acute on Chronic Liver Failure in 30 participants. Completed in 15 January 2020.

Timeline

9 July 2017

Primary endpoint
31 December 2019

15 January 2020

Quick facts

Lead sponsor	Yaqrit Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	device feasibility
Enrollment	30
Start date	9 July 2017
Primary completion	31 December 2019
Estimated completion	15 January 2020
Sites	12 locations across France, Denmark, Belgium, Austria, United Kingdom, Germany, Romania, Spain

Drugs / interventions tested

• DIALIVE Liver Dialysis Device

Conditions studied

• Acute on Chronic Liver Failure — all drugs for Acute on Chronic Liver Failure →

Sponsor

Yaqrit Ltd

Who can join

Adults 18 to 81, any sex, with Acute on Chronic Liver Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Albumin in decompensated cirrhosis: new concepts and perspectives.
   Bernardi M, Angeli P, Claria J, Moreau R, et al · · 2020 · cited 228× · PMID 32102926 · DOI 10.1136/gutjnl-2019-318843
2. Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure.
   Agarwal B, Cañizares RB, Saliba F, Ballester MP, et al · · 2023 · cited 44× · PMID 37268222 · DOI 10.1016/j.jhep.2023.03.013
3. Liver cirrhosis and immune dysfunction.
   Hasa E, Hartmann P, Schnabl B. · · 2022 · cited 44× · PMID 35792761 · DOI 10.1093/intimm/dxac030
4. Approaches for patients with very high MELD scores.
   Artru F, Samuel D. · · 2019 · cited 19× · PMID 32039352 · DOI 10.1016/j.jhepr.2019.02.008
5. Alcohol and Acute-on-Chronic Liver Failure.
   Ballester MP, Sittner R, Jalan R. · · 2022 · cited 14× · PMID 36157143 · DOI 10.1016/j.jceh.2021.12.010
6. Acute-on-Chronic Liver Failure in Cirrhosis.
   Gambino C, Piano S, Angeli P. · · 2021 · cited 14× · PMID 34640424 · DOI 10.3390/jcm10194406
7. Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis.
   Juanola O, Francés R, Caparrós E. · · 2024 · cited 12× · PMID 38312368 · DOI 10.1159/000535962
8. Potential therapies for acute-on-chronic liver failure.
   Morrison MA, Artru F, Trovato FM, Triantafyllou E, et al · · 2025 · cited 12× · PMID 36800487 · DOI 10.1111/liv.15545