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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Drug: Livact


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Livact<br>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. | Drug: Livact<br>* 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.<br>* Other names: Branched chain amino acid;|
| No Intervention: General nutritional support<br>General nutritional support | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cirrhosis-related complications including death |  | After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score