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

Sponsor
Soonchunhyang University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02755701
Collaborator
Severance Hospital (Other), Kyunghee University (Other), Wonju Severance Christian Hospital (Other), Korea University Anam Hospital (Other), Hanyang University (Other), Stanford University (Other)
188
Enrollment
8
Locations
2
Arms
29
Duration (Months)
23.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.

Condition or Disease Intervention/Treatment Phase
  • Drug: Branched-chain Amino Acid
  • Drug: Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
188 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BCAA group

Branched-chain amino acid, 4.15g, Tid

Drug: Branched-chain Amino Acid
BCAA (livact) will be administered 3 times a day during 24 weeks
Other Names:
  • Livact®

    		•
    Placebo Comparator: Placebo group

    Placebo, 4.15g, Tid

    Drug: Placebo
    Placebo will be administered in the same way

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum albumin level [24 week]

    Secondary Outcome Measures

    1. Change in serum albumin level [12 week]

    2. Rates of albumin normalization [12, 24 week]

    3. Change in dose of diuretics [12, 24 week]

    4. Improvement in terms of severity of ascites (International Ascites Club grade) [24 week]

    5. Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc) [24 week]

    6. Improvement in Child-Pugh score, class [24 week]

    7. Change in MELD, MELD-Na [24 week]

    8. Improvement in sarcopenia [24 week]

    9. Change in muscle mass [24 week]

    10. Change in muscle strength [24 week]

    11. Improvement in SF-36(short form-36) [24 week]

    12. Change in HOMA-IR(homeostatic model assessment-insulin resistance) [24 week]

    Other Outcome Measures

    1. Change in serum cystatin c [12, 24 week]

    2. Change in HVPG(hepatic venous pressure gradient) [24 week]

    3. Radiological characteristics of patients who have reaction to the branched-chain amino acid agent [24 week]

    4. Change in serum creatinine [12, 24 week]

    5. Improvement on PHES (psychometric hepatic encephalopathy score) [24 week]

    6. Improvement on relative adrenal insufficiency [24 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Palo Alto California United States 94305
    2 Wonju severance christian hospital Wonju Gangwon Korea, Republic of 26426
    3 Soon Chun Hyang University Bucheon Hospital Bucheon Gyeonggi do Korea, Republic of 14584
    4 Kyunghee university hospital Seoul Korea, Republic of 02477
    5 Korea university anam hospital Seoul Korea, Republic of 02841
    6 Severance hospital Seoul Korea, Republic of 03722
    7 Soonchunhyang university seoul hospital Seoul Korea, Republic of 04401
    8 Hanyang university hospital Seoul Korea, Republic of 04763

    Sponsors and Collaborators

    • Soonchunhyang University Hospital
    • Severance Hospital
    • Kyunghee University
    • Wonju Severance Christian Hospital
    • Korea University Anam Hospital
    • Hanyang University
    • Stanford University

    Investigators

    • Principal Investigator: Sang Gyune Kim, Soon Chun Hyang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sang Gyune Kim, Associate professor, Soonchunhyang University Hospital
    ClinicalTrials.gov Identifier:
    NCT02755701
    Other Study ID Numbers:
    • LIV_ACT Trial_I
    First Posted:
    Apr 29, 2016
    Last Update Posted:
    Sep 2, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Ascites

    Study Results

    No Results Posted as of Sep 2, 2016