CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
Transient elastographyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02904252
NCT02904252N/ACompleted

The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital

Mahidol University·observational·Posted Sep 16, 2016·Updated Mar 23, 2017

In Brief

An observational study evaluating Transient elastography for Hepatitis C and 2 related conditions. Completed, enrolled 158 participants across 1 site.

Detailed Summary

The primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital. The secondary objective is to identify the effect of HCV infection as well as the risk factors of advanced liver disease and liver cirrhosis in these patients The third objective is to identify the role of serum HA level and fibrotest in the prediction of cirrhosis in these patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 16, 2016
Enrollment StartJan 1, 2016
Primary CompletionOct 31, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.8 years ago

Interventions

Transient elastographyother

Transient elastography (TE) is an ultrasound-based device used for measuring the degree of liver stiffness. A transducer probe is used to create mild amplitude and low frequency vibrations (50 Hz) that transmitted through the liver tissue. This results in an elastic shear wave that propagates through the underlying liver tissue. The probe then utilizes pulse-echo ultrasound to follow the propagation of the shear wave and to measure its velocity. The velocity of the wave is directly related to tissue stiffness which correlates with fibrosis. The sensitivity and the specificity of TE is between 68%-88% and between 66%-100%, respectively for the detection of significant liver fibrosis (METAVIR score F\>2).