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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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ClinicalTrials.gov Identifier: NCT02755701
Recruitment Status : Unknown
Verified August 2016 by Sang Gyune Kim, Soonchunhyang University Hospital.
Recruitment status was:  Recruiting
First Posted : April 29, 2016
Last Update Posted : September 2, 2016
Sponsor:
Collaborators:
Severance Hospital
Kyunghee University
Wonju Severance Christian Hospital
Korea University Anam Hospital
Hanyang University
Stanford University
Information provided by (Responsible Party):
Sang Gyune Kim, Soonchunhyang University Hospital

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
Cirrhosis Ascites 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: Livact®

Placebo Comparator: Placebo group
Placebo, 4.15g, Tid
Drug: Placebo
Placebo will be administered in the same way




Primary Outcome Measures :
  1. Change in serum albumin level [ Time Frame: 24 week ]

Secondary Outcome Measures :
  1. Change in serum albumin level [ Time Frame: 12 week ]
  2. Rates of albumin normalization [ Time Frame: 12, 24 week ]
  3. Change in dose of diuretics [ Time Frame: 12, 24 week ]
  4. Improvement in terms of severity of ascites (International Ascites Club grade) [ Time Frame: 24 week ]
  5. Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc) [ Time Frame: 24 week ]
  6. Improvement in Child-Pugh score, class [ Time Frame: 24 week ]
  7. Change in MELD, MELD-Na [ Time Frame: 24 week ]
  8. Improvement in sarcopenia [ Time Frame: 24 week ]
  9. Change in muscle mass [ Time Frame: 24 week ]
  10. Change in muscle strength [ Time Frame: 24 week ]
  11. Improvement in SF-36(short form-36) [ Time Frame: 24 week ]
  12. Change in HOMA-IR(homeostatic model assessment-insulin resistance) [ Time Frame: 24 week ]

Other Outcome Measures:
  1. Change in serum cystatin c [ Time Frame: 12, 24 week ]
  2. Change in HVPG(hepatic venous pressure gradient) [ Time Frame: 24 week ]
  3. Radiological characteristics of patients who have reaction to the branched-chain amino acid agent [ Time Frame: 24 week ]
  4. Change in serum creatinine [ Time Frame: 12, 24 week ]
  5. Improvement on PHES (psychometric hepatic encephalopathy score) [ Time Frame: 24 week ]
  6. Improvement on relative adrenal insufficiency [ Time Frame: 24 week ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02755701


Contacts
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Contact: Sang Gyune Kim 82-32-621-5079 mcnulty@schmc.ac.kr

Locations
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United States, California
Stanford University School of Medicine Not yet recruiting
Palo Alto, California, United States, 94305
Contact: W.Ray Kim, Professor    650-725-6511    wrkim@stanford.edu   
Principal Investigator: W.Ray Kim, Professor         
Korea, Republic of
Wonju severance christian hospital Recruiting
Wonju, Gangwon, Korea, Republic of, 26426
Contact: Moon Young Kim, Professor         
Principal Investigator: Moon Young Kim         
Soon Chun Hyang University Bucheon Hospital Recruiting
Bucheon, Gyeonggi do, Korea, Republic of, 14584
Contact: Sang Gyune Kim, Professor    82-32-621-5079    mcnulty@schmc.ac.kr   
Principal Investigator: Sang Gyune Kim         
Kyunghee university hospital Recruiting
Seoul, Korea, Republic of, 02477
Contact: Jae Jun Shim, Professor         
Principal Investigator: Jae Jun Shim         
Korea university anam hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Yeon Seok Seo, Professor         
Principal Investigator: Yeon Seok Seo         
Severance hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jun Yong Park, Professor         
Principal Investigator: Jun Yong Park         
Soonchunhyang university seoul hospital Recruiting
Seoul, Korea, Republic of, 04401
Contact: Soung Won Jeong, Professor         
Principal Investigator: Soung Won Jeong         
Hanyang university hospital Recruiting
Seoul, Korea, Republic of, 04763
Contact: Dae Won Jun, Professor         
Principal Investigator: Dae Won Jun         
Sponsors and Collaborators
Soonchunhyang University Hospital
Severance Hospital
Kyunghee University
Wonju Severance Christian Hospital
Korea University Anam Hospital
Hanyang University
Stanford University
Investigators
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Principal Investigator: Sang Gyune Kim Soon Chun Hyang University

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Responsible Party: Sang Gyune Kim, Associate professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02755701     History of Changes
Other Study ID Numbers: LIV_ACT Trial_I
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ascites
Pathologic Processes