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

S

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

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

Trial contacts and locations

8

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Central trial contact

Sang Gyune Kim

Data sourced from clinicaltrials.gov

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