Evaluation of APRI and FIB-4 scoring systems for hepatic fibrosis in chronic hepatitis patients in Thailand

Not Applicable

Completed

• Conditions: Benefits to community and social organizations: If found that APRI and FIB- 4 scores correlate well with liver stiffness detected by transient elastography Can accurately indicate significant fibrosis; aspartate aminotransferase to platelet ratio index, biomarker, fibrosis, fibrosis 4, hepatitis C, noninvasive, transient elastography.

• Registration Number: TCTR20200313002
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-01
• Study Start: 2020-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2242

Inclusion Criteria

Patients who underwent successful LSM using TE (from transient elastography database) in 11 participated centers from January 1st, 2009 †August 31st, 2017 whose indications of fibrosis assessment were one of the following;
1)Chronic HBV infection (CHB): defined as HBsAg+ for at least six months, who were not treated with antiviral agent(s) or interferon treatment at the time of LSM.
2)Chronic HCV infection (CHC): defined as antiHCV+ and detectable viremia by HCV RNA, who were not treated with Peginterferon+Ribavirin or direct antiviral agents (DAA) at the time of LSM.
3)NAFLD: defined as hepatic steatosis detected by imaging and/or evidence of steatohepatitis from liver histology plus history of alcohol intake <20 gm/day and HBsAg- antiHCV-

Exclusion Criteria

1) Chronic hepatitis patients from other causes other than CHB, CHC, and NAFLD as described above
2) Patients with co-infection with human immunodeficiency virus (HIV), or HBV/HCV co-infection
3) No available laboratory results of AST, ALT, platelet level within 3 months of LSM
4) Patients with coexisted diseases of either active hemolysis at time of AST/ALT measurement, immune mediated thrombocytopenia, or hematologic malignancies
5) Patients with AST or ALT > 5 times above ULN
6) The subsequent TE measurement(s) in the same patients after the first enrollment

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fibrosis stage 3 year Outcome measurement is fibrosis stage using TE as reference standard, which were validated in numero

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A