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

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Cirrhosis, Ascites

In brief

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

Key facts

Study ID

NCT02755701

Run by

Soonchunhyang University Hospital

People needed

188

Starts

2016-07-01

Expected to finish

2018-12-01

Last updated by the study team

2016-09-02

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hanyang university hospital — Seoul, South Korea (enrolling)
• Wonju severance christian hospital — Wŏnju, Gangwon-do, South Korea (enrolling)
• Soon Chun Hyang University Bucheon Hospital — Bucheon-si, Gyeonggi-do, South Korea (enrolling)
• Kyunghee university hospital — Seoul, South Korea (enrolling)
• Korea university anam hospital — Seoul, South Korea (enrolling)
• Severance hospital — Seoul, South Korea (enrolling)
• Soonchunhyang university seoul hospital — Seoul, South Korea (enrolling)
• Stanford University School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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