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The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites
Recruiting
I'm InterestedTrial 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
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 InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
W.Ray Kim, Professor
650-725-6511