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

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Trial ID: NCT02755701

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

Stanford Investigator(s)

W. Ray Kim
W. Ray Kim

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility


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

Intervention(s):

drug: Branched-chain Amino Acid

drug: Placebo

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
W.Ray Kim, Professor
650-725-6511