Acute-On-Chronic Liver Failure Clinical Trial
Official title:
A Phase 1b Open-Label Study Assessing the Pharmacokinetics, Tolerability, and Safety of Oral Trimetazidine in Subjects With Acute-on-Chronic Liver Failure
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). ;
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