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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02837302

Acronym

BRAVE

Enrollment

1470

Registered

2016-07-19

Start date

2012-11-30

Completion date

2018-06-30

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score

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.

Interventions

DRUGLivact

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026