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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20200313002
Enrollment
Unknown
Registered
2020-03-13
Start date
2017-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benefits to community and social organizations: If found that APRI and FIB&#45

Interventions

Patients with chronic hepatitis from hepatitis B virus (HBV) infection&#44
hepatitis C virus (HCV) infection&#44
NAFLD&#44
and alcoholic liver disease (ALD) who underwent LSM using transient elastography in 11 participated centers in Thailand.
Diagnostic
Chronic hepatitis patients who require hepatic fibrosis assessment

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who underwent successful LSM using TE (from transient elastography database) in 11 participated centers from January 1st&#44; 2009 – August 31st&#44; 2017 whose indications of fibrosis assessment were one of the following; 1)Chronic HBV infection (CHB): defined as HBsAg+ for at least six months&#44; 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&#44; 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&#45; antiHCV&#45;

Exclusion criteria

Exclusion criteria: 1) Chronic hepatitis patients from other causes other than CHB&#44; CHC&#44; and NAFLD as described above 2) Patients with co&#45;infection with human immunodeficiency virus (HIV)&#44; or HBV/HCV co&#45;infection 3) No available laboratory results of AST&#44; ALT&#44; platelet level within 3 months of LSM 4) Patients with coexisted diseases of either active hemolysis at time of AST/ALT measurement&#44; immune mediated thrombocytopenia&#44; 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

Design outcomes

Primary

MeasureTime frame
fibrosis stage 3 year Outcome measurement is fibrosis stage using TE as reference standard&#44; which were validated in numero

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactWattana Sukeepaisarnjaroen

Khonkaen University

wattanasukee@gmail.com0873731133

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026