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

NCT ID: NCT02837302

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis

Keywords

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Liver cirrhosis Branched chain amino acid End-Stage Liver Disease score

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Livact

Intervention Type DRUG

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

General nutritional support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Branched chain amino acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Young Tak

Division of Gastroenterology & Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Young Tak, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook national university hospital, department of internal medicine

Locations

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Kyungpook national university hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BRAVE_prospective

Identifier Type: -

Identifier Source: org_study_id