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

Phase 4

• Conditions: Ascites; Cirrhosis
• Interventions: Drug: Branched-chain Amino Acid; Drug: Placebo

• Registration Number: NCT02755701
• Lead Sponsor: Soonchunhyang University Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Study Start: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCAA group	Branched-chain Amino Acid	Branched-chain amino acid, 4.15g, Tid
Placebo group	Placebo	Placebo, 4.15g, Tid

Primary Outcome Measures

Name	Time	Method
Change in serum albumin level	24 week

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Wonju severance christian hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Korea university anam hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee university hospital; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi do, Korea, Republic of

Severance hospital; 🇰🇷 Seoul, Korea, Republic of

Hanyang university hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang university seoul hospital; 🇰🇷 Seoul, Korea, Republic of