Immunological Measurement of Aspartate/Alanine Aminotransferase

Chronic Liver Disease and Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562585
• Other study ID #: ASTALT
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: March 2, 2017

Study information

• Verified date: June 2018
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: March 2, 2017
• Est. primary completion date: December 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Liver Disease and Cirrhosis
• Liver Cirrhosis
• Liver Diseases

Intervention

Diagnostic Test:
• with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HVPG score	efficacy of HVPG in predicting liver fibrosis and inflammation.	3 years