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

Soon Chun Hyang University

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis; Ascites

Treatments: Drug: Placebo; Drug: Branched-chain Amino Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02755701

LIV_ACT Trial_I

Details and patient eligibility

About

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

Full 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.

Enrollment: 188 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups, including a placebo group

BCAA group

Experimental group

Description:

Branched-chain amino acid, 4.15g, Tid

Treatment:

Drug: Branched-chain Amino Acid

Placebo group

Placebo Comparator group

Description:

Placebo, 4.15g, Tid

Treatment:

Drug: Placebo