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The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites

Primary Purpose

Cirrhosis, Ascites

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Branched-chain Amino Acid
Placebo
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 19 and ≤ 70 years;
  • Presence of liver cirrhosis
  • Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1)
  • No administration of diuretics and BCAA within the past 1 week
  • Voluntary consent to take part in this trial

Exclusion Criteria:

  • Child-Pugh score > 12
  • Having been diagnosed as HCC within the past 5 years
  • Serum creatinine > 1.5mg/dl
  • Serum bilirubin > 5.0mg/dl
  • Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3)
  • Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month
  • Presence of serious cardiac or respiratory disease
  • Contraindicated to either diuretics or BCAA
  • Having commenced anti-viral treatment against hepatitis C, B within the past 1 month
  • Pregnant or lactating women
  • Chronic alcohol taker
  • Woman patients who do not agree to the contraception from baseline to 12 month
  • Unsuitable patients judged by investigator
  • Patients participating in another clinical trial within 1 month

Sites / Locations

  • Stanford University School of Medicine
  • Wonju severance christian hospitalRecruiting
  • Soon Chun Hyang University Bucheon HospitalRecruiting
  • Kyunghee university hospitalRecruiting
  • Korea university anam hospitalRecruiting
  • Severance hospitalRecruiting
  • Soonchunhyang university seoul hospitalRecruiting
  • Hanyang university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BCAA group

Placebo group

Arm Description

Branched-chain amino acid, 4.15g, Tid

Placebo, 4.15g, Tid

Outcomes

Primary Outcome Measures

Change in serum albumin level

Secondary Outcome Measures

Change in serum albumin level
Rates of albumin normalization
Change in dose of diuretics
Improvement in terms of severity of ascites (International Ascites Club grade)
Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
Improvement in Child-Pugh score, class
Change in MELD, MELD-Na
Improvement in sarcopenia
Change in muscle mass
Change in muscle strength
Improvement in SF-36(short form-36)
Change in HOMA-IR(homeostatic model assessment-insulin resistance)

Full Information

First Posted
April 21, 2016
Last Updated
August 31, 2016
Sponsor
Soonchunhyang University Hospital
Collaborators
Severance Hospital, Kyunghee University, Wonju Severance Christian Hospital, Korea University Anam Hospital, Hanyang University, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02755701
Brief Title
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites
Official Title
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites: A Multi-center, Randomized, Double-blind, Placebo-controlled, Investigator Initiated Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
Collaborators
Severance Hospital, Kyunghee University, Wonju Severance Christian Hospital, Korea University Anam Hospital, Hanyang University, Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Detailed Description
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered. The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BCAA group
Arm Type
Experimental
Arm Description
Branched-chain amino acid, 4.15g, Tid
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo, 4.15g, Tid
Intervention Type
Drug
Intervention Name(s)
Branched-chain Amino Acid
Other Intervention Name(s)
Livact®
Intervention Description
BCAA (livact) will be administered 3 times a day during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered in the same way
Primary Outcome Measure Information:
Title
Change in serum albumin level
Time Frame
24 week
Secondary Outcome Measure Information:
Title
Change in serum albumin level
Time Frame
12 week
Title
Rates of albumin normalization
Time Frame
12, 24 week
Title
Change in dose of diuretics
Time Frame
12, 24 week
Title
Improvement in terms of severity of ascites (International Ascites Club grade)
Time Frame
24 week
Title
Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
Time Frame
24 week
Title
Improvement in Child-Pugh score, class
Time Frame
24 week
Title
Change in MELD, MELD-Na
Time Frame
24 week
Title
Improvement in sarcopenia
Time Frame
24 week
Title
Change in muscle mass
Time Frame
24 week
Title
Change in muscle strength
Time Frame
24 week
Title
Improvement in SF-36(short form-36)
Time Frame
24 week
Title
Change in HOMA-IR(homeostatic model assessment-insulin resistance)
Time Frame
24 week
Other Pre-specified Outcome Measures:
Title
Change in serum cystatin c
Time Frame
12, 24 week
Title
Change in HVPG(hepatic venous pressure gradient)
Time Frame
24 week
Title
Radiological characteristics of patients who have reaction to the branched-chain amino acid agent
Time Frame
24 week
Title
Change in serum creatinine
Time Frame
12, 24 week
Title
Improvement on PHES (psychometric hepatic encephalopathy score)
Time Frame
24 week
Title
Improvement on relative adrenal insufficiency
Time Frame
24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 19 and ≤ 70 years; Presence of liver cirrhosis Serum albumin level ≤ 3.5g/dl, ultrasound or CT scan confirmed ascites (≥Grade 1) No administration of diuretics and BCAA within the past 1 week Voluntary consent to take part in this trial Exclusion Criteria: Child-Pugh score > 12 Having been diagnosed as HCC within the past 5 years Serum creatinine > 1.5mg/dl Serum bilirubin > 5.0mg/dl Presence of such complications as SBP, or hepatic encephalopathy(West Haven grade ≥ 3) Patients who experienced organ failure by acute exacerbation of liver cirrhosis within the past 1 month Presence of serious cardiac or respiratory disease Contraindicated to either diuretics or BCAA Having commenced anti-viral treatment against hepatitis C, B within the past 1 month Pregnant or lactating women Chronic alcohol taker Woman patients who do not agree to the contraception from baseline to 12 month Unsuitable patients judged by investigator Patients participating in another clinical trial within 1 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Gyune Kim
Phone
82-32-621-5079
Email
mcnulty@schmc.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Gyune Kim
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W.Ray Kim, Professor
Phone
650-725-6511
Email
wrkim@stanford.edu
First Name & Middle Initial & Last Name & Degree
W.Ray Kim, Professor
Facility Name
Wonju severance christian hospital
City
Wonju
State/Province
Gangwon
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moon Young Kim, Professor
First Name & Middle Initial & Last Name & Degree
Moon Young Kim
Facility Name
Soon Chun Hyang University Bucheon Hospital
City
Bucheon
State/Province
Gyeonggi do
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Gyune Kim, Professor
Phone
82-32-621-5079
Email
mcnulty@schmc.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang Gyune Kim
Facility Name
Kyunghee university hospital
City
Seoul
ZIP/Postal Code
02477
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Jun Shim, Professor
First Name & Middle Initial & Last Name & Degree
Jae Jun Shim
Facility Name
Korea university anam hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon Seok Seo, Professor
First Name & Middle Initial & Last Name & Degree
Yeon Seok Seo
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yong Park, Professor
First Name & Middle Initial & Last Name & Degree
Jun Yong Park
Facility Name
Soonchunhyang university seoul hospital
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soung Won Jeong, Professor
First Name & Middle Initial & Last Name & Degree
Soung Won Jeong
Facility Name
Hanyang university hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Won Jun, Professor
First Name & Middle Initial & Last Name & Degree
Dae Won Jun

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites

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