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Trial record 2 of 22 for:    IL28B Polymorphism in

Prevalence of IL28B Polymorphism in Hepatitis C Patients

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ClinicalTrials.gov Identifier: NCT03415009
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hepatitis C

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 Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of IL28B Polymorphism in Hepatitis C Patients in Singapore and Its Effect on the Outcome of Hepatitis C Treatment
Study Start Date : June 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. the prevalence of genetic variants for IL28B SNPs (rs 12979860 and rs 8099917) in HCV patients in Singapore. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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


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).


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hepatitis C patients with genotype 1, 2/3
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415009


Locations
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Investigators
Principal Investigator: Poh Yen Loh Changi General Hospital

Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT03415009     History of Changes
Other Study ID Numbers: CG12Aug02-13
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Changi General Hospital:
IL28B gene

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections