Clinical trial NCT03562585: Immunological Measurement of Aspartate/Alanine Aminotransferase
Official title: Immunological Measurement of Aspartate/Alanine Aminotransferase Utilizing Monoclonal Anti-bodies in Predicting Liver Fibrosis and Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Liver Disease and Cirrhosis
Keywords: Chronic hepatitis B
Alanine Aminotransferase
Aspartate Aminotransferase
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 219
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation
timeFrame: 3 years
Secondary outcomes:
measure: HVPG score
timeFrame: 3 years
Other outcomes:
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