Immunological Measurement of Aspartate/Alanine Aminotransferase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-01

Study Completion Date

2017-03-02

Brief Summary

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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.

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Detailed Description

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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

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Chronic Liver Disease and Cirrhosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Efficacy of immunoassay in liver fibrosis

efficacy of immunoassay in liver fibrosis in patients with CHB

with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Intervention Type DIAGNOSTIC_TEST

with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Interventions

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with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with CHB, who simultaneously underwent HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were prospectively recruited.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No