Prevalence of IL28B Polymorphism in Hepatitis C Patients

Completed

• Conditions: Hepatitis C

• Registration Number: NCT03415009
• Lead Sponsor: Changi General Hospital

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-02-16
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	To study the correlation between genetic variants and treatment response

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore