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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyungpook National University; Kyungpook National University Hospital
• Collaborator: Samil Pharmaceutical Co., Ltd.

Criteria

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