NCT03737448

TRimetazidine for acUte on Chronic Liver Failure STudy

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Martin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Trimetazidine	Subjects with receive up to 60 mg daily

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-11-09
• Last updated: 2021-03-04

Locations

24 sites across 5 countries: Austria, Belgium, France, Germany, Spain