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

Trial ID or NCT#

NCT02755701

Status

recruiting iconRECRUITING

Purpose

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

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

Eligibility Criteria

Ages Eligible for Study: 19 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

W. Ray Kim
W. Ray Kim
Transplant hepatologist, Hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)

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Contact

W.Ray Kim, Professor
650-725-6511