Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

Status Completed

Clinical Trial Summary

The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.

Clinical Trial Description

A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04759521
Study type	Observational [Patient Registry]
Source	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Contact
Status	Completed
Phase
Start date	January 3, 2019
Completion date	December 18, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04496882` - Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue	Phase 4
Completed	`NCT04083716` - A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults	Phase 1
Not yet recruiting	`NCT03038802` - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection	Phase 1/Phase 2
Completed	`NCT05310487` - Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects	Phase 1
Recruiting	`NCT06070051` - Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy	Phase 1
Terminated	`NCT05001022` - A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects	Phase 1
Recruiting	`NCT04139850` - The Establishment of Korean Hepatitis B Patients Cohort
Recruiting	`NCT05343481` - Efficacy of VTP-300 in Chronic Hepatitis B Infection	Phase 2
Not yet recruiting	`NCT05490836` - Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients	N/A
Recruiting	`NCT04543565` - Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study	Phase 3
Active, not recruiting	`NCT02894918` - A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs	Phase 4
Not yet recruiting	`NCT02793791` - Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients	N/A
Recruiting	`NCT02287857` - Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B	N/A
Recruiting	`NCT01965418` - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial	Phase 4
Recruiting	`NCT01491295` - Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients	Phase 4
Terminated	`NCT01872988` - Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma	Phase 3
Recruiting	`NCT01487876` - Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients	Phase 2
Not yet recruiting	`NCT01436539` - Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients	Phase 4
Completed	`NCT01531166` - A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon	N/A
Recruiting	`NCT01360879` - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease	N/A