NCT03562585

Immunological Measurement of Aspartate/Alanine Aminotransferase

Immunological Measurement of Aspartate/Alanine Aminotransferase Utilizing Monoclonal Anti-bodies in Predicting Liver Fibrosis and Inflammation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 219 (actual)
• Sponsor: Chuncheon Sacred Heart Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Previous reports have suggested that ALT-immunoglobulin complex was increased according to the severity of the liver disease, and high concentration of mAST and this might indicate a severely damaged liver. Immunoassay might be useful as a screening method in the differ-ential diagnosis of liver fibrosis according to patients. In this study, the efficacy of immunoas-say in the prediction of liver fibrosis in patients with chronic hepatitis B (CHB) was evaluated.

Detailed description

Enzymatic analysis of aspartate/alanine aminotransferase (AST/ALT) does not exactly represent the progression of liver fibrosis. Immunoassay for the AST (cytoplasmic \[c\] AST/mitochondrial \[m\] AST) and ALT (ALT1/ALT2) have been suggested as one of the alternatives for the enzy-matic analysis. We evaluated the efficacy of immunoassay in predicting liver fibrosis and in-flammation. A total of 219 patients with chronic hepatitis B (CHB) who underwent hepatic ve-nous pressure gradient (HVPG) and liver biopsy before antiviral therapy were recruited. Serum samples were prepared from blood during HVPG. The liver function test including enzymatic AST/ALT and immunological cAST, mAST, ALT1 and ALT2 were checked with sandwich ELI-SA immunoassay with fluorescence labeled monoclonal antibodies, and were compared with the METAVIR stage of live fibrosis and the Knodell grade of inflammation.

Conditions

• Chronic Liver Disease and Cirrhosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies	with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-12-30
• Completion: 2017-03-02
• First posted: 2018-06-19
• Last updated: 2018-06-19