Last updated on November 2019

TRimetazidine for acUte on Chronic Liver Failure STudy


Brief description of study

The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.

Detailed Study Description

The study will assess the PK, tolerability, and safety of oral trimetazidine administered to subjects with acute-on-chronic (ACLF) Grades 1 and 2 with liver failure and a range of renal function. Subjects will receive up to 60 mg/day for 28 days.

Two groups of subjects will be enrolled:

Group 1

  • AD with serum creatinine 1 and < 2 mg/dL, OR
  • ACLF 1 with
  • liver failure and serum creatinine 1.5 and < 2 mg/dl, or
  • liver failure and West Haven grade 1-2 hepatic encephalopathy, or
  • coagulation failure and serum creatinine 1.5 and < 2 mg/dl, or
  • coagulation failure and West Haven grade 1-2 hepatic encephalopathy, OR
  • ACLF 2 with
  • liver failure and coagulation failure, or
  • liver failure and West Haven grade 3-4 hepatic encephalopathy.

Group 2

  • ACLF 1 with renal failure (serum creatinine 2.0 and < 3.5 mg/dL), OR
  • ACLF 2 with
  • liver failure and renal failure (serum creatinine 2.0 and < 3.5 mg/dL), or
  • coagulation failure and renal failure (serum creatinine 2.0 and < 3.5 mg/dL).

Clinical Study Identifier: NCT03737448

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H pital Paul Brousse

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