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

NCT02904252 | Completed

• 1 other identifier: 481/2558
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; Fibrosis; Thalassemia

Keywords

Transient elastography; Fibrotest

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (2)

• 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

  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.

  1 year

Study Arms (1)

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

Interventions

Transient elastography OTHER

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).

Also known as: Fibroscan

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (8)

• Borgna-Pignatti C, Garani MC, Forni GL, Cappellini MD, Cassinerio E, Fidone C, Spadola V, Maggio A, Restivo Pantalone G, Piga A, Longo F, Gamberini MR, Ricchi P, Costantini S, D'Ascola D, Cianciulli P, Lai ME, Carta MP, Ciancio A, Cavalli P, Putti MC, Barella S, Amendola G, Campisi S, Capra M, Caruso V, Colletta G, Volpato S. Hepatocellular carcinoma in thalassaemia: an update of the Italian Registry. Br J Haematol. 2014 Oct;167(1):121-6. doi: 10.1111/bjh.13009. Epub 2014 Jul 3.

  PMID: 24992281 BACKGROUND

• Kountouras D, Tsagarakis NJ, Fatourou E, Dalagiorgos E, Chrysanthos N, Berdoussi H, Vgontza N, Karagiorga M, Lagiandreou A, Kaligeros K, Voskaridou E, Roussou P, Diamanti-Kandarakis E, Koskinas J. Liver disease in adult transfusion-dependent beta-thalassaemic patients: investigating the role of iron overload and chronic HCV infection. Liver Int. 2013 Mar;33(3):420-7. doi: 10.1111/liv.12095.

  PMID: 23402611 BACKGROUND

• Wilder J, Patel K. The clinical utility of FibroScan((R)) as a noninvasive diagnostic test for liver disease. Med Devices (Auckl). 2014 May 3;7:107-14. doi: 10.2147/MDER.S46943. eCollection 2014.

  PMID: 24833926 BACKGROUND

• Fraquelli M, Cassinerio E, Roghi A, Rigamonti C, Casazza G, Colombo M, Massironi S, Conte D, Cappellini MD. Transient elastography in the assessment of liver fibrosis in adult thalassemia patients. Am J Hematol. 2010 Aug;85(8):564-8. doi: 10.1002/ajh.21752.

  PMID: 20658587 BACKGROUND

• Fucharoen S, Winichagoon P. Haemoglobinopathies in southeast Asia. Indian J Med Res. 2011 Oct;134(4):498-506.

  PMID: 22089614 BACKGROUND

• Wanachiwanawin W, Luengrojanakul P, Sirangkapracha P, Leowattana W, Fucharoen S. Prevalence and clinical significance of hepatitis C virus infection in Thai patients with thalassemia. Int J Hematol. 2003 Nov;78(4):374-8. doi: 10.1007/BF02983565.

  PMID: 14686498 RESULT

• Papastamataki M, Delaporta P, Premetis E, Kattamis A, Ladis V, Papassotiriou I. Evaluation of liver fibrosis in patients with thalassemia: the important role of hyaluronic acid. Blood Cells Mol Dis. 2010 Oct 15;45(3):215-8. doi: 10.1016/j.bcmd.2010.06.002. Epub 2010 Jul 6.

  PMID: 20605573 RESULT

• El-Shabrawi MH, Zein El Abedin MY, Omar N, Kamal NM, Elmakarem SA, Khattab S, El-Sayed HM, El-Hennawy A, Ali AS. Predictive accuracy of serum hyaluronic acid as a non-invasive marker of fibrosis in a cohort of multi-transfused Egyptian children with beta-thalassaemia major. Arab J Gastroenterol. 2012 Jun;13(2):45-8. doi: 10.1016/j.ajg.2012.06.006. Epub 2012 Jul 11.

  PMID: 22980590 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Clotted blood and serum

MeSH Terms

Conditions

Hepatitis C; Fibrosis; Thalassemia

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tawesak Tanwandee, Assoc.Prof.

  Division of Gastroenterology, Faculty of Medicine, Siriraj hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: January 1, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)