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

Liver Cirrhosis Clinical Trial

— BRAVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02837302
• Other study ID #: BRAVE_prospective
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 13, 2014
• Last updated: October 27, 2016
• Start date: November 2012
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1470
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Kyungpook National University	Samil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of cirrhosis-related complications including death		After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death	No