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

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02755701
• Other study ID #: LIV_ACT Trial_I
• Status: Recruiting
• Phase: Phase 4
• First received: April 21, 2016
• Last updated: August 31, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Soonchunhyang University Hospital
• Contact: Sang Gyune Kim
• Phone: 82-32-621-5079
• Email: mcnulty[@]schmc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Cirrhosis

Intervention

Drug:
• Branched-chain Amino Acid
BCAA (livact) will be administered 3 times a day during 24 weeks
• Placebo
Placebo will be administered in the same way

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon	Gyeonggi do
Korea, Republic of	Hanyang university hospital	Seoul
Korea, Republic of	Korea university anam hospital	Seoul
Korea, Republic of	Kyunghee university hospital	Seoul
Korea, Republic of	Severance hospital	Seoul
Korea, Republic of	Soonchunhyang university seoul hospital	Seoul
Korea, Republic of	Wonju severance christian hospital	Wonju	Gangwon
United States	Stanford University School of Medicine	Palo Alto	California

Sponsors (7)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital	Hanyang University, Korea University Anam Hospital, Kyunghee University, Severance Hospital, Stanford University, Wonju Severance Christian Hospital

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in serum cystatin c		12, 24 week	No
Other	Change in HVPG(hepatic venous pressure gradient)		24 week	No
Other	Radiological characteristics of patients who have reaction to the branched-chain amino acid agent		24 week	No
Other	Change in serum creatinine		12, 24 week	No
Other	Improvement on PHES (psychometric hepatic encephalopathy score)		24 week	No
Other	Improvement on relative adrenal insufficiency		24 week	No
Primary	Change in serum albumin level		24 week	No
Secondary	Change in serum albumin level		12 week	No
Secondary	Rates of albumin normalization		12, 24 week	No
Secondary	Change in dose of diuretics		12, 24 week	No
Secondary	Improvement in terms of severity of ascites (International Ascites Club grade)		24 week	No
Secondary	Development rate of cirrhotic complications(including acute kidney injury, hepatic encephalopathy, variceal bleeding, peritonitis, etc)		24 week	No
Secondary	Improvement in Child-Pugh score, class		24 week	No
Secondary	Change in MELD, MELD-Na		24 week	No
Secondary	Improvement in sarcopenia		24 week	No
Secondary	Change in muscle mass		24 week	No
Secondary	Change in muscle strength		24 week	No
Secondary	Improvement in SF-36(short form-36)		24 week	No
Secondary	Change in HOMA-IR(homeostatic model assessment-insulin resistance)		24 week	No