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

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Livact

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 Type: Interventional
• Enrollment (Anticipated): 1470
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Branched chain amino acid
No Intervention: General nutritional support

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Collaborators: Samil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Won Young Tak, M.D., Ph.D., Kyungpook national university hospital, department of internal medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Liver cirrhosis; Branched chain amino acid; End-Stage Liver Disease score
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: BRAVE_prospective