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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
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief 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.


Condition or disease Intervention/treatment
Hepatitis C Fibrosis Thalassemia Other: Transient elastography

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study group
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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
Clotted blood and serum


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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
Study Population
The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital
Criteria

Inclusion Criteria:

  1. 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
  2. Age equal to or more than 18 years
  3. Previous history of blood transfusion

Exclusion Criteria:

  1. Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
  2. Unwilling to participate
  3. Patient who receiving or completed treatment of hepatitis C

Information from the National Library of Medicine

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


Locations
Thailand
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Tawesak Tanwandee, Assoc.Prof. Division of Gastroenterology, Faculty of Medicine, Siriraj hospital

Publications of Results:
Other Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02904252     History of Changes
Other Study ID Numbers: 481/2558
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.

Keywords provided by Mahidol University:
Transient elastography
Fibrotest

Additional relevant MeSH terms:
Hepatitis C
Thalassemia
beta-Thalassemia
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn