Clinical trial NCT02837302: Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease
Official title: Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE): Korean Nation-wide Multicenter Retrospective and Prospective Observational Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
Branched chain amino acid
End-Stage Liver Disease score
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Samil Pharmaceutical Co., Ltd.
First posted: 2016-07-19
Enrollment: 1470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
timeFrame: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Secondary outcomes:
measure: Incidence of cirrhosis-related complications including death
timeFrame: After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
Study officials:
affiliation: Kyungpook national university hospital, department of internal medicine
name: Won Young Tak, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: