Prevalence of IL28B Polymorphism in Hepatitis C Patients

Hepatitis C Clinical Trial

Official title:

Prevalence of IL28B Polymorphism in Hepatitis C Patients in Singapore and Its Effect on the Outcome of Hepatitis C Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415009
• Other study ID #: CG12Aug02-13
• Status: Completed
• Phase: N/A
• First received: February 16, 2016
• Last updated: January 23, 2018
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Response to peginterferon and ribavirin treatment in hepatitis C (HCV) depends on viral and host factors. Single nucleotide polypmorphisms (SNP) near to IL28B gene (especially at rs12979860 and rs8099917) are strongly associated with the response to treatment in HCV genotype 1 infection, less so in HCV genotype 2/3 infection. CC genotype in rs12979860 and TT genotype at rs8099917 are associated with good treatment outcome. Asian populations have high prevalence of CC genotype in other studies, which can explain relatively good response to peginterferon/ ribavirin in genotype 1 infection in Asians compared with Caucasians.

Description:

The prevalence of different genotypes of IL28B polymorphism in the local population will be studied. DNA will be extracted from the whole blood sample of hepatitis C patients with genotype 1, 2 and 3 infection. It will be amplified by real-time PCR and subsequently analysed for the genotypes of IL28B SNPs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with positive HCV IgG (EIA or RIBA test) and positive HCV RNA test (RT-PCR)

• HCV genotypes 1, 2 or 3 (determined by Versant™ HCV genotype Assay LiPA 2.0)

• with or without HCV treatment (peginterferon/ ribavirin).

Exclusion Criteria:

-Patients with acute hepatitis C infection.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore.		Baseline
Secondary	The distribution of the different SNP variants in different ethnic groups (Chinese, Malay, Indian and others)		Baseline
Secondary	The association of the genetic variants and the treatment response in patients receiving peg-interferon/ ribavirin therapy.	To study the correlation between genetic variants and treatment response	Baseline