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Immunological Measurement of Aspartate/Alanine Aminotransferase

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ClinicalTrials.gov Identifier: NCT03562585
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ki Tae Suk, Chuncheon Sacred Heart Hospital

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.

Condition or disease Intervention/treatment
Chronic Liver Disease and Cirrhosis 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.

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Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunological Measurement of Aspartate/Alanine Aminotransferase Utilizing Monoclonal Anti-bodies in Predicting Liver Fibrosis and Inflammation
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : December 30, 2010
Actual Study Completion Date : March 2, 2017


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




Primary Outcome Measures :
  1. A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation [ Time Frame: 3 years ]
    efficacy of immunoassay in predicting liver fibrosis and inflammation.


Secondary Outcome Measures :
  1. HVPG score [ Time Frame: 3 years ]
    efficacy of HVPG in predicting liver fibrosis and inflammation.


Biospecimen Retention:   Samples Without DNA
serum


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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Responsible Party: Ki Tae Suk, Hallym university College of Medicine, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03562585     History of Changes
Other Study ID Numbers: ASTALT
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ki Tae Suk, Chuncheon Sacred Heart Hospital:
Chronic hepatitis B
Alanine Aminotransferase
Aspartate Aminotransferase

Additional relevant MeSH terms:
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N-Methylaspartate
Liver Diseases
Chronic Disease
Liver Cirrhosis
Digestive System Diseases
Disease Attributes
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action