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

K

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

Trial design

1,470 participants in 2 patient groups

Livact
Active Comparator group
Description:
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.
Treatment:
Drug: Livact
General nutritional support
No Intervention group
Description:
General nutritional support

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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