Clinical trial NCT02755701: The Effect of Branched-chain Amino Acid on the Improvement of 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Ascites
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Kyunghee University
name: Wonju Severance Christian Hospital
name: Korea University Anam Hospital
name: Hanyang University
name: Stanford University
First posted: 2016-04-29
Enrollment: 188
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum albumin level
timeFrame: 24 week
Secondary outcomes:
measure: Change in serum albumin level
timeFrame: 12 week
measure: Rates of albumin normalization
timeFrame: 12, 24 week
measure: Change in dose of diuretics
timeFrame: 12, 24 week
measure: Improvement in terms of severity of ascites (International Ascites Club grade)
timeFrame: 24 week
measure: Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)
timeFrame: 24 week
measure: Improvement in Child-Pugh score, class
timeFrame: 24 week
measure: Change in MELD, MELD-Na
timeFrame: 24 week
measure: Improvement in sarcopenia
timeFrame: 24 week
measure: Change in muscle mass
timeFrame: 24 week
measure: Change in muscle strength
timeFrame: 24 week
measure: Improvement in SF-36(short form-36)
timeFrame: 24 week
measure: Change in HOMA-IR(homeostatic model assessment-insulin resistance)
timeFrame: 24 week
Other outcomes:
measure: Change in serum cystatin c
timeFrame: 12, 24 week
measure: Change in HVPG(hepatic venous pressure gradient)
timeFrame: 24 week
measure: Radiological characteristics of patients who have reaction to the branched-chain amino acid agent
timeFrame: 24 week
measure: Change in serum creatinine
timeFrame: 12, 24 week
measure: Improvement on PHES (psychometric hepatic encephalopathy score)
timeFrame: 24 week
measure: Improvement on relative adrenal insufficiency
timeFrame: 24 week
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Wonju
country: Korea, Republic of
facility: Wonju severance christian hospital
state: Gangwon
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi do
city: Seoul
country: Korea, Republic of
facility: Kyunghee university hospital
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang university seoul hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang university hospital
Study officials:
affiliation: Soon Chun Hyang University
name: Sang Gyune Kim
role: PRINCIPAL_INVESTIGATOR
References: