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

Acute on Chronic Liver Failure Clinical Trial

Official title:
A Multi-centre, Randomised Controlled Study, to Evaluate the Safety and Performance of The DIALIVE Liver Dialysis Device (LDD) in Patients With Acute on Chronic Liver Failure (ACLF) Versus Standard of Care (SOC)

Clinical Trial Summary

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).

Clinical Trial Description

The First-In-Man study will evaluate the safety and performance of DIALIVE Liver Dialysis Device in Acute on Chronic Liver Failure (ACLF) patients and will compare the outcome with patients treated under standard of care (SOC). The hypothesis is that DIALIVE will significantly improve the prognosis of ACLF patients by modulating systemic inflammation. The target patient population are men and women ≥18 years, ≤81yr. Patients with ACLF grade 1 and ACLF grade 2 on the background of alcoholic cirrhosis. During the study, inclusion criteria were expanded to include also AKI-1 and ACLF 3a patients. Treatment will be undertaken in an intensive care (ICU) or renal dialysis unit setting if the patients are randomised to the DIALIVE treatment arm. For patients randomised to the 'Standard of care' arm, the location of treatment (ICU or general ward) will be determined by their clinical need and will be decided by the site Principal Investigator. This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 733057. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03065699
Study type Interventional
Source Yaqrit Ltd
Contact
Status Completed
Phase N/A
Start date July 9, 2017
Completion date January 15, 2020
View Details
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