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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02904252
Date of registration: 13/09/2016
Prospective Registration: No
Primary sponsor: Mahidol University
Public title: The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
Scientific title: The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital
Date of first enrolment: January 1, 2016
Target sample size: 158
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02904252
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Thailand
Contacts
Name:     Tawesak Tanwandee, Assoc.Prof.
Address: 
Telephone:
Email:
Affiliation:  Division of Gastroenterology, Faculty of Medicine, Siriraj hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Hepatitis C
Fibrosis
Thalassemia
Intervention(s)
Other: Transient elastography
Primary Outcome(s)
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(s)
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]
Secondary ID(s)
481/2558
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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