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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Cirrhosis, Ascites

Intervention / Treatment
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* Drug: Branched-chain Amino Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCAA group<br>Branched-chain amino acid, 4.15g, Tid | Drug: Branched-chain Amino Acid<br>* BCAA (livact) will be administered 3 times a day during 24 weeks<br>* Other names: Livact®;|
| Placebo Comparator: Placebo group<br>Placebo, 4.15g, Tid | Drug: Placebo<br>* Placebo will be administered in the same way<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum albumin level |  | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum albumin level |  | 12 week | 
| Rates of albumin normalization |  | 12, 24 week | 
| Change in dose of diuretics |  | 12, 24 week | 
| Improvement in terms of severity of ascites (International Ascites Club grade) |  | 24 week | 
| Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc) |  | 24 week | 
| Improvement in Child-Pugh score, class |  | 24 week | 
| Change in MELD, MELD-Na |  | 24 week | 
| Improvement in sarcopenia |  | 24 week | 
| Change in muscle mass |  | 24 week | 
| Change in muscle strength |  | 24 week | 
| Improvement in SF-36(short form-36) |  | 24 week | 
| Change in HOMA-IR(homeostatic model assessment-insulin resistance) |  | 24 week |