Immunological Measurement of Aspartate/Alanine Aminotransferase
1 other identifier
observational
219
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2007
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2017
CompletedFirst Submitted
Initial submission to the registry
May 13, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedJune 19, 2018
June 1, 2018
4 years
May 13, 2018
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
HVPG score
3 years
Study Arms (1)
Efficacy of immunoassay in liver fibrosis
efficacy of immunoassay in liver fibrosis in patients with CHB
Interventions
with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
Eligibility Criteria
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
You may qualify if:
- patients with CHB, who simultaneously underwent HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were prospectively recruited.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hallym university College of Medicine
Study Record Dates
First Submitted
May 13, 2018
First Posted
June 19, 2018
Study Start
January 1, 2007
Primary Completion
December 30, 2010
Study Completion
March 2, 2017
Last Updated
June 19, 2018
Record last verified: 2018-06