Branched-chain Amino Acid (BCAA) on Progression of Advanced Liver Disease (BRAVE)
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ClinicalTrials.gov Identifier: NCT02837302 |
Recruitment Status : Unknown
Verified October 2016 by Won Young Tak, Kyungpook National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : October 31, 2016
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Condition or disease | Intervention/treatment | Phase |
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Liver Cirrhosis | Drug: Livact | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1470 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | November 2012 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | June 2018 |

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.
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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 Name: Branched chain amino acid |
No Intervention: General nutritional support
General nutritional support
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837302
Korea, Republic of | |
Kyungpook national university hospital | |
Daegu, Korea, Republic of, 700-721 |
Principal Investigator: | Won Young Tak, M.D., Ph.D. | Kyungpook national university hospital, department of internal medicine |
Responsible Party: | Won Young Tak, Division of Gastroenterology & Hepatology, Kyungpook National University Hospital |
ClinicalTrials.gov Identifier: | NCT02837302 |
Other Study ID Numbers: |
BRAVE_prospective |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | October 31, 2016 |
Last Verified: | October 2016 |
Liver cirrhosis Branched chain amino acid End-Stage Liver Disease score |
Liver Cirrhosis Liver Diseases Fibrosis Pathologic Processes Digestive System Diseases |