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

Kyungpook National University

Status and phase

Unknown

Phase 4

Conditions

Liver Cirrhosis

Treatments

Drug: Livact

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02837302

BRAVE_prospective

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,470 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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