Ascites, Cirrhosis
Conditions
Brief summary
To compare the efficacy of branched-chain amino acid in serum albumin level in cirrhotic patients with ascites.
Detailed description
Branched-chain amino acid (BCAA) is known to reduce the relapse rate of liver cancer as it is associated with insulin resistance and has been reported to improve the progression of liver fibrosis when used in combination with an angiotensin-converting enzyme. With regard to the effect of liver function improvement, in a research conducted in South Korea, approximately 41.2% of the patients showed recovery of the normal albumin level when BCAA was administered to them for about 10 weeks during radiation therapy for liver cancer. Additionally, in other overseas researches, the changes in the values of total protein and albumin were significantly smaller in the patients who underwent transarterial chemoembolization (TACE) to whom BCAA was administered than in those to whom BCAA was not administered. The hypothesis of this study is that the serum albumin value will be increased significantly in the cirrhotic patients with ascites to whom BCAA is administered than the patients to whom placebo is administered.
Interventions
BCAA (livact) will be administered 3 times a day during 24 weeks
DRUGPlacebo
Placebo will be administered in the same way
Sponsors
Severance Hospital
Kyunghee University
Wonju Severance Christian Hospital
Korea University Anam Hospital
Hanyang University
Stanford University
Soonchunhyang University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum albumin level | 24 week |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in terms of severity of ascites (International Ascites Club grade) | 24 week |
| Change in MELD, MELD-Na | 24 week |
| Improvement in sarcopenia | 24 week |
| Change in muscle mass | 24 week |
| Change in muscle strength | 24 week |
| Improvement in SF-36(short form-36) | 24 week |
| Change in HOMA-IR(homeostatic model assessment-insulin resistance) | 24 week |
| Change in serum albumin level | 12 week |
| Rates of albumin normalization | 12, 24 week |
| Change in dose of diuretics | 12, 24 week |
| Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc) | 24 week |
| Improvement in Child-Pugh score, class | 24 week |
Other
| Measure | Time frame |
|---|---|
| Radiological characteristics of patients who have reaction to the branched-chain amino acid agent | 24 week |
| Change in serum creatinine | 12, 24 week |
| Improvement on PHES (psychometric hepatic encephalopathy score) | 24 week |
| Improvement on relative adrenal insufficiency | 24 week |
| Change in HVPG(hepatic venous pressure gradient) | 24 week |
| Change in serum cystatin c | 12, 24 week |
Countries
South Korea, United States
Contacts
Primary ContactSang Gyune Kim
Outcome results
None listed