N/A
N=412
FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis
Liver Fibrosis · Cirrhosis · Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT02476695 ↗Enrolled (actual)
412
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold Standard for Judging CHB Liver Fibrosis Stage — 0.846; 0.850; 0.908; 0.874 probability
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FibroTouch Examination (Device); FibroScan Examination (Device); Ultrasonic B Examination (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Clinical Value Evaluation of FibroTouch for Non-invasive Diagnosis of Liver Fibrosis in Patients With Chronic Hepatitis B by Using Liver Pathology as the Gold Standard for Judging CHB Liver Fibrosis Stage |
0.846; 0.850; 0.908; 0.874 | — |
Summary
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference.
Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
Eligibility Criteria
Inclusion Criteria
- Subjects with age 18-65 years, both gender
- Subjects with history of HBV or HBsAg positive > 6 months up to enrollment
- Subjects with qualified liver biopsy specimens within three months (before or after) of Fibrotouch examination for pathological staging
- Subjects without chemical therapy history of powerful medicine to lower enzyme in the two weeks before blood biochemistry tests (e.g. dimethyl diphenyl bicarboxylate and bicyclol)
- Subjects must agree and sign the informed consent form
Exclusion Criteria
- Subjects who are unable or unwilling to sign informed consent form
- Subjects who have merger of hepatitis C, alcohol and non-alcoholic fatty liver diseases, autoimmune liver diseases, inherited metabolic liver diseases, biliary systemic diseases or liver and gall parasitic diseases
- Subjects who have other serious chronic disorders or history of malignancy
- Subjects with ALT ≥5 ULN in the past 1 month
- Subjects with WBC<3.5×10^9/L, PLT<60×10^9/L, PTA<60%
- Subjects with DBIL≥1.5 ULN
- Subjects with decompensated cirrhosis (especially the people with ascites)
- Pregnant or lactating women, or women who has a pregnant plan and don't want to birth control in the study period
- Subjects who have wound on the right upper abdomen recently
- Subjects who have various space-occupying tumor or cyst in right liver
- Subjects who have none or limited legal capacity
Data sourced from ClinicalTrials.gov (NCT02476695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.