Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease

Phase 4

• Conditions: Liver Cirrhosis
• Interventions: Drug: Livact

• Registration Number: NCT02837302
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

Protein-calorie malnutrition is frequently observed in patients with advanced liver cirrhosis. There have been continued interests in potential benefits of long-term oral branched-chain amino acid supplement in improving severity of liver disease. However, there are limited evidences in literature. The aim of this study is to evaluate the efficacy of oral branched-chain amino acid in patients with advanced liver cirrhosis.

Detailed Description

This study is a multicenter retrospective cohort study involving thirteen centers in Korea nation-wide. The inclusion criteria are liver cirrhosis patients with Child-Pugh score 8 to 10. The major exclusion criteria are abnormal serum creatinine level, and hepatocellular carcinoma with viable tumor. The investigators analyzed improvement of Model for End-Stage Liver Disease score, Child-Pugh score, incidence of cirrhosis-related complications, and event free survival.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1470

Inclusion Criteria

• Advanced liver cirrhosis patients with Child-Pugh score 8 to 10

Exclusion Criteria

• Diagnosis of malignancy (except hepatocellular carcinoma) within 3 years or untreated malignancy
• Major organ failure (heart, lung and kidney) need to admission or medical therapy or dialysis
• Patients already on a waiting list or being considered for major organ transplantation.
• Serum creatinine above upper normal range (>1.5 mg/dL)
• Patients treating with albumin replacement regularly
• Viable hepatocellular carcinoma or advanced Barcelona Clinic Liver Cancer stage or hepatocellular carcinoma below 6 months life expectancy
• Patients being impossible to secession of alcohol consumption
• Patients being impossible to oral ingestion or oral medication
• Pregnancy or being considered for pregnancy
• Breast feeding
• Amyotrophic lateral sclerosis
• Patients with other metabolic disorder presenting branched-chain ketoaciduria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Livact	Livact	Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months.

Primary Outcome Measures

Name	Time	Method
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio	After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death

Secondary Outcome Measures

Name	Time	Method
Incidence of cirrhosis-related complications including death	After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Korea, Republic of