Immunological Measurement of Aspartate/Alanine Aminotransferase

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease and Cirrhosis
• Intervention / Treatment: Diagnostic test: with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

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.

• Study Type: Observational
• Enrollment (Actual): 219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Between January 2007 and December 2010, patients with CHB, who simultaneously underwent HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were prospectively recruited.

They are all admitted for the evaluation of CHB. Age: 20-70 Gender: both, Korean

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients were selected according to inclusion criteria with CHB and then excluded according to exclusion criteria: i. they had other cause with liver disease: ii. decompensated cirrhosis and re-ceived antiviral treatment within the previous 6 months. iii. malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation	efficacy of immunoassay in predicting liver fibrosis and inflammation.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HVPG score	efficacy of HVPG in predicting liver fibrosis and inflammation.	3 years

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 30, 2010
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: May 13, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Chronic hepatitis B; Aspartate Aminotransferase; Alanine Aminotransferase
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: ASTALT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No