NCT02837302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,470

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

5.1 years

First QC Date

May 13, 2014

Last Update Submit

October 27, 2016

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosisBranched chain amino acidEnd-Stage Liver Disease score

Outcome Measures

Primary Outcomes (1)

  • End-Stage Liver Disease score was calculated using serum total bilirubin, creatinine, international normalized ratio

    After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death

Secondary Outcomes (1)

  • Incidence of cirrhosis-related complications including death

    After enrollment, the patients was assessed every 3 or 6 months for 2 years or until death

Study Arms (2)

Livact

ACTIVE COMPARATOR

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

General nutritional support

NO INTERVENTION

General nutritional support

Interventions

LivactDRUG

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.

Also known as: Branched chain amino acid
Livact

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced liver cirrhosis patients with Child-Pugh score 8 to 10

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook national university hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Won Young Tak, M.D., Ph.D.

    Kyungpook national university hospital, department of internal medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Gastroenterology & Hepatology

Study Record Dates

First Submitted

May 13, 2014

First Posted

July 19, 2016

Study Start

November 1, 2012

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

KR(1)