Back to resultsBranched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE)
Primary Purpose
Liver Cirrhosis
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Livact
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score
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
Sites / Locations
- Kyungpook national university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Livact
General nutritional support
Arm 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.
General nutritional support
Outcomes
Primary Outcome Measures
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
Secondary Outcome Measures
Incidence of cirrhosis-related complications including death
Full Information
NCT ID
NCT02837302
First Posted
May 13, 2014
Last Updated
October 27, 2016
Sponsor
Kyungpook National University Hospital
Collaborators
Samil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02837302
Brief Title
Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
Collaborators
Samil Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver cirrhosis, Branched chain amino acid, End-Stage Liver Disease score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1470 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Livact
Arm Type
Active Comparator
Arm 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.
Arm Title
General nutritional support
Arm Type
No Intervention
Arm Description
General nutritional support
Intervention Type
Drug
Intervention Name(s)
Livact
Other Intervention Name(s)
Branched chain amino acid
Intervention 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.
Primary Outcome Measure Information:
Title
End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio
Time Frame
After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
Secondary Outcome Measure Information:
Title
Incidence of cirrhosis-related complications including death
Time Frame
After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Young Tak, M.D., Ph.D.
Organizational Affiliation
Kyungpook national university hospital, department of internal medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook national university hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease
We'll reach out to this number within 24 hrs