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Clinical Trials/NCT03415009
NCT03415009CompletedNot Applicable

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

Changi General Hospital1 site in 1 country39 target enrollmentStarted: June 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore.

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore.

Time Frame: Baseline

Secondary Outcomes

  • The distribution of the different SNP variants in different ethnic groups (Chinese, Malay, Indian and others)(Baseline)
  • The association of the genetic variants and the treatment response in patients receiving peg-interferon/ ribavirin therapy.(Baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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