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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
Sponsor:
Collaborator:
Samil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Won Young Tak, Kyungpook National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: Livact Phase 4

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.
Study Design
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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

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Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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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
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
Contacts and Locations
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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


Locations
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Korea, Republic of
Kyungpook national university hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
Samil Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Won Young Tak, M.D., Ph.D. Kyungpook national university hospital, department of internal medicine
More Information
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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
Keywords provided by Won Young Tak, Kyungpook National University Hospital:
Liver cirrhosis
Branched chain amino acid
End-Stage Liver Disease score
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Fibrosis
Pathologic Processes
Digestive System Diseases