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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
Subjects with receive up to 60 mg daily
Medical University of Graz
Graz, Austria
Medical University of Innsbruck
Innsbruck, Austria
plasma pharmacokinetics
Cmax
Time frame: 28 days
plasma pharmacokinetics
AUC
Time frame: 28 days
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Adverse events
Time frame: 90 days
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...and 14 more locations