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Immunological Measurement of Aspartate/Alanine Aminotransferase

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03562585
Enrollment
219
Registered
2018-06-19
Start date
2007-01-01
Completion date
2017-03-02
Last updated
2018-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease and Cirrhosis

Keywords

Chronic hepatitis B, Alanine Aminotransferase, Aspartate Aminotransferase

Brief 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.

Interventions

DIAGNOSTIC_TESTwith sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Sponsors

Chuncheon Sacred Heart Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation3 yearsefficacy of immunoassay in predicting liver fibrosis and inflammation.

Secondary

MeasureTime frameDescription
HVPG score3 yearsefficacy of HVPG in predicting liver fibrosis and inflammation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026