Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute on Chronic Liver Failure
  • Age: Between 18 - 81 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male or female subjects aged 18 years 81yr who have given informed consent to participate in the study and are able to understand and comply with the requirements of the study.
  • History indicative of alcohol-related cirrhosis based on clinical, radiological and/or histological evidence.
  • History of an acute decompensating event (including but not limited to ascites, gastrointestinal bleeding, hepatic encephalopathy and/or acute bacterial infections), occurring within 6 weeks of screening.
  • Subject meets the definition of ACLF Grade 1 or Grade 2 (using the CLIF-C OF score system [Moreau et al. Gastroenterology 2013; Jalan et al. J Hepatol 2014]).
  • Where a subject has received corticosteroids for alcohol-induced ACLF, is unresponsive to at least 7 days of treatment (where lack of response defined as a reduction in bilirubin <25% over a 7 day treatment period).
  • No evidence of untreated infection. Where a subject has one or more underlying infections, he/she may be entered into the study provided that appropriate antibiotics (as determined by the investigator) have been administered for at least 48 hours prior to randomisation.

Exclusion Criteria:

  • Co-infection with HIV and AIDS defining illness.
  • Subjects with acute or sub-acute liver failure without underlying cirrhosis.
  • Subjects with severe thrombocytopaenia, defined by the platelet count of < 40,000 / mm3 or rapid reduction in platelet count (> 50% reduction) 24 hrs prior to inclusion.
  • Subjects with cirrhosis who develop decompensation at any time in the post-operative period following partial hepatectomy.
  • Subjects with evidence of uncontrolled infection.
  • Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) <30 mL/min for 3 months or longer prior to screening.
  • Subjects with hypotension requiring the use of vasopressors (other than terlipressin for the treatment of hepatorenal syndrome, or following variceal bleeding).
  • Subjects with evidence of significant and/or uncontrolled bleeding; patients with gastrointestinal bleeding can be enrolled 48 hours after the control of bleeding.
  • Hepatic encephalopathy Grade 3 or 4 (West Haven Criteria).
  • Subjects with active or history of non hepatic malignancy unless adequately treated or in complete remission for five or more years.
  • Patients with HCC outside Milan criteria.
  • Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study.
  • Any subject who has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device in the course of the study; concomitant observational studies are allowed.
  • Uncontrolled seizures.
  • Subjects diagnosed with Creutzfeldt-Jakob disease.
  • If female: known pregnancy or lactating.
  • Subjects unable to consent for themselves.
  • patients with a known allergy to heparine of have type II thrombocytopaenia caused by heparin (HIT syndrome type II)

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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