NCT02755701

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Ascites

Interventions

Type	Name	Description
DRUG	Branched-chain Amino Acid	BCAA (livact) will be administered 3 times a day during 24 weeks
DRUG	Placebo	Placebo will be administered in the same way

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2016-04-29
• Last updated: 2016-09-02

Locations

8 sites across 2 countries: United States, South Korea