Immunological Measurement of Aspartate/Alanine Aminotransferase
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|ClinicalTrials.gov Identifier: NCT03562585|
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Chuncheon Sacred Heart Hospital
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital
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.
|Condition or disease||Intervention/treatment|
|Chronic Liver Disease and Cirrhosis||Diagnostic Test: with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies|
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.
|Study Type :||Observational|
|Actual Enrollment :||219 participants|
|Official Title:||Immunological Measurement of Aspartate/Alanine Aminotransferase Utilizing Monoclonal Anti-bodies in Predicting Liver Fibrosis and Inflammation|
|Actual Study Start Date :||January 1, 2007|
|Actual Primary Completion Date :||December 30, 2010|
|Actual Study Completion Date :||March 2, 2017|
Efficacy of immunoassay in liver fibrosis
efficacy of immunoassay in liver fibrosis in patients with CHB
Diagnostic Test: with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
Primary Outcome Measures :
- A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation [ Time Frame: 3 years ]efficacy of immunoassay in predicting liver fibrosis and inflammation.
Secondary Outcome Measures :
- HVPG score [ Time Frame: 3 years ]efficacy of HVPG in predicting liver fibrosis and inflammation.
Biospecimen Retention: Samples Without DNA
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