TRimetazidine for acUte on Chronic Liver Failure STudy — TRUST  

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

Status Suspended

Clinical Trial Summary

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

• NCT number: NCT03737448
• Study type: Interventional
• Source: Martin Pharmaceuticals
• Status: Suspended
• Phase: Phase 1
• Start date: November 28, 2018
• Completion date: June 30, 2021