Prevalence of IL28B Polymorphism in Hepatitis C Patients | NCT03415009

Studies
Prevalence of IL28B Polymorphism in Hepatitis C Patients

NCT03415009

Sponsor

Changi General Hospital

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 16, 2016

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.	To study the correlation between genetic variants and treatment response

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Hepatitis C patients with genotype 1, 2/3

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poh Yen Loh	Changi General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changi General Hospital		Singapore		529889	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

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