Cut off value of noninvasive biomarkers and liver biopsy for staging liver fibrosis in chronic hepatitis patients

Phase 3

• Conditions: The cut off value for diagnose significant fibrosis by 12 non- invasive tests (AAR, APRI, The FIB- 4 score, The Fibro index, The Forns index, The FibroQ, The Hepascore, Fibroscan&#44

• Registration Number: TCTR20200319003
• Lead Sponsor: Srinagarind hospital Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-19
• Study Completion: 2021-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

Description of subjects and main criteria for inclusion•Patients age 18-65 in the Srinagarind Hospital between years 2016-2018 and receive a diagnosis viral hepatitis B or C infection or non-alcoholic steatohepatitis (NASH) one only.
•ECOG performance status 0-1
•Patients must not treat with Peginterferon alfa (type 2a / 2b) in combination with Ribavirin before.
•Stop drinking alcohol more than six months.
•Child-Pugh score <= 6
•If cancer patients must undergo treatment to cure (curative aim) and disease-free period exceeding six months.
•Volunteers participated in the research.

Exclusion Criteria

Description of main exclusion criteria•Patients with HIV co-infection.
•Patients with contraindications to liver biopsy: patients do not cooperate, patients with risk bleeding cannot be solved by providing blood components (INR> 1.5 platelet <80,000). , Patients with skin infections in the ribs, Patients with obstructive jaundice, Patients with ascites, Patients suspected liver nodules.
•Patients with uncontrolled underlying diseases, such as heart failure, renal failure, diabetes, hyper or hypothyroidism, hypertension, ischemic heart diseases, COPD, major depressive disorder.
•Patients do not stop antiplatelet at least 10 days.
•Pregnancy.
•Organ transplant.
•Patients during chemotherapy.
•Patients with acute hemolysis or extra hepatic cholestasis.
•Patients with chronic hemolysis or Gilbert's syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cut point non invasive test at the beginning of study Fibrotest fibrometer elf fibroscan fibrometer and lab

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of non invasive test at the beginning of study Sensitivity specificity PPV NPV AUROC