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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200319003
Enrollment
Unknown
Registered
2020-03-19
Start date
2017-04-10
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

The cut off value for diagnose significant fibrosis by 12 non&#45

Interventions

Non invasive test such as Fibroscan Fibrotest ElF test M2BPGI Fibrometer Basic Lab
Experimental No treatment
Non invasive test

Sponsors

Srinagarind hospital Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Description of subjects and main criteria for inclusion • Patients age 18&#45;65 in the Srinagarind Hospital between years 2016&#45;2018 and receive a diagnosis viral hepatitis B or C infection or non&#45;alcoholic steatohepatitis (NASH) one only. • ECOG performance status 0&#45;1 • Patients must not treat with Peginterferon alfa (type 2a / 2b) in combination with Ribavirin before. • Stop drinking alcohol more than six months. • Child&#45;Pugh score <= 6 • If cancer patients must undergo treatment to cure (curative aim) and disease&#45;free period exceeding six months. • Volunteers participated in the research.

Exclusion criteria

Exclusion criteria: Description of main exclusion criteria • Patients with HIV co&#45;infection. • Patients with contraindications to liver biopsy: patients do not cooperate&#44; patients with risk bleeding cannot be solved by providing blood components (INR> 1.5 platelet <80&#44;000). &#44; Patients with skin infections in the ribs&#44; Patients with obstructive jaundice&#44; Patients with ascites&#44; Patients suspected liver nodules. • Patients with uncontrolled underlying diseases&#44; such as heart failure&#44; renal failure&#44; diabetes&#44; hyper or hypothyroidism&#44; hypertension&#44; ischemic heart diseases&#44; COPD&#44; 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&#39;s syndrome.

Design outcomes

Primary

MeasureTime frame
Cut point non invasive test at the beginning of study Fibrotest fibrometer elf fibroscan fibrometer and lab

Secondary

MeasureTime frame
Diagnostic performance of non invasive test at the beginning of study Sensitivity specificity PPV NPV AUROC

Countries

Thailand

Contacts

Public ContactWattana Sukeepaisarnjaroen
wattana@gmail.com0873731133

Outcome results

None listed

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