The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
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|ClinicalTrials.gov Identifier: NCT02904252|
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : March 23, 2017
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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.
|Condition or disease||Intervention/treatment|
|Hepatitis C Fibrosis Thalassemia||Other: Transient elastography|
|Study Type :||Observational|
|Actual Enrollment :||158 participants|
|Official Title:||The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||October 31, 2016|
|Actual Study Completion Date :||October 31, 2016|
Population : The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital Clinical data, Laboratory data (Blood samples) and Transient elastography data will be collected from all participants, as previously described.
Other: Transient elastography
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).
Other Name: Fibroscan
- 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 [ Time Frame: 1 year ]
- Effect of HCV infection and the risk factors of advanced liver disease and liver cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion [ Time Frame: 1 year ]
- Role of serum HA level and fibrotest in the prediction of cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital. [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Previously diagnosed thalassemia major, for example homozygous beta thalassemia or beta thalassemia/hemoglobin E disease or thalassemia intermedia such as hemoglobin H disease or homozygous Hb CS
- Age equal to or more than 18 years
- Previous history of blood transfusion
- Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
- Unwilling to participate
- Patient who receiving or completed treatment of hepatitis C
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904252
|Faculty of Medicine Siriraj Hospital|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Tawesak Tanwandee, Assoc.Prof.||Division of Gastroenterology, Faculty of Medicine, Siriraj hospital|
|Responsible Party:||Mahidol University|
|Other Study ID Numbers:||
|First Posted:||September 16, 2016 Key Record Dates|
|Last Update Posted:||March 23, 2017|
|Last Verified:||March 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Due to patients confidentiality in study protocol. The individual level data will not be released.|
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn