Prevalence of IL28B Polymorphism in Hepatitis C Patients

NCT03415009 | Completed

• 1 other identifier: CG12Aug02-13
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

IL28B gene

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (2)

• 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

Study Arms (1)

HCV genotype 1 and genotype 2/3

DNA extracted from whole blood sample will be used as template for real-time PCR amplification. It will be analyzed for the genotypes of IL28B SNPs (genotype CC/CT/TT for rs12979860 and TT/GT/GG for rs8099917).

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis C patients with genotype 1, 2/3

You may qualify if:

• 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).

You may not qualify if:

• Patients with acute hepatitis C infection.

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from whole blood sample will be used as template for real-time PCR amplification. It will be analyzed for the genotypes of IL28B SNPs (genotype CC/CT/TT for rs12979860 and TT/GT/GG for rs8099917).

MeSH Terms

Conditions

Hepatitis C

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

Study Officials

• Poh Yen Loh

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: January 30, 2018
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)