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Completed

NCT Number: NCT03415009

Prevalence of IL28B Polymorphism in Hepatitis C Patients

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  1. The distribution of the different SNP variants in different ethnic groups (Chinese, Malay, Indian and others)

    Time frame: Baseline

  2. The association of the genetic variants and the treatment response in patients receiving peg-interferon/ ribavirin therapy.

    Time frame: Baseline

    To study the correlation between genetic variants and treatment response

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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