The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Pa… (NCT02755701) | Clinical Trial Compass
UnknownPhase 4
The Effect of Branched-chain Amino Acid on the Improvement of Serum Albumin Level in Cirrhotic Patients With Ascites
United States, South Korea188 participantsStarted 2016-07
Plain-language summary
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Who can participate
Age range19 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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