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TerminatedNCT01100749Updated May 28, 2015

Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada

An observational study in Chronic Hepatitis C - Genotype 3, sponsored by University Health Network, Toronto. Terminated at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by University Health Network, Toronto · Observational

Why this study was terminated
Low recruitment
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study summary

Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6 known genotypes and within each there are several subtypes. Although all genotypes are distributed worldwide some are more common in certain countries and/or among certain populations.

Read the detailed description

Genotype 3(G3) infection is the predominant type in South East Asia (Bangladesh, Pakistan, India and Sri Lanka). In addition, because of the "promiscuous exposure" to hepatitis C amongst injection drug users, it is not unusual for the latter to be infected with G3 as well. There are several subtypes of G3. Viral genotype has long been recognized as a major factor influencing the response to interferon-based therapy. Patients infected with G2 and G3 respond much better to current therapy with peginterferon and ribavirin than those infected with G1 and G4. Most studies have grouped patients with G2 and G3 together, with few published comparisons of rates of viral clearance between these two favourable genotypes.

More recently it has become evident that in all individuals with chronic hepatitis C, the presence of insulin resistance, with or without the accompanying metabolic syndrome, is a major factor which influencing the response to antiviral therapy in CHC.

Very recently it has been reported and confirmed by several sites worldwide that specific polymorphisms of the IL28 gene are closely correlated with response to antiviral therapy in genotype 1 CHC. Interestingly, the polymorphisms were also shown to segregate according to ethnicity and may explain, at least in part, the marked differences in treatment response between different ethnic groups.

02

Conditions studied

  • Chronic Hepatitis C - Genotype 3

Keywords

  • Hepatitis C
  • Genotype 3
  • Demographics
  • Genetics
  • Metabolic status
03

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 25 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult subjects across Canada with chronic hepatitis C, genotype 3 infection who are treatment naïve.

Inclusion criteria

  • Infected with only genotype 3, hepatitis C
  • Treatment naïve before current course of therapy
  • Age 18 or older

Exclusion criteria

Exclusion Criteria:

  • Under age 18
  • Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
  • Prior treatment for Hepatitis C aside from herbal remedies
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Factors associated with treatment outcome in genotype 3 in CHC

    To study how factors such as viral subtype, ethnicity, insulin resistance, IL28 genotype and severity of liver disease contribute to treatment response.

    Time frame: Within 12 weeks before starting treatment compared to end of treatment response

07

Study locations

2 sites
  • Toronto General Hospital - Dr. M. Sherman Liver Clinic
    Toronto, Ontario M5G 2C4, Canada
  • University Health Network - Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
08

References and documents

Publications

  • Freshwater DA, O'Donnell K, Mutimer DJ. Inferior response of Asian vs non-Asian hepatitis C genotype 3 infection to combination antiviral therapy. J Viral Hepat. 2008 Feb;15(2):115-9. doi: 10.1111/j.1365-2893.2007.00899.x. PubMed 18184194 ↗
  • Isharwal S, Misra A, Wasir JS, Nigam P. Diet & insulin resistance: a review & Asian Indian perspective. Indian J Med Res. 2009 May;129(5):485-99. PubMed 19675375 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01100749
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Apr 9, 2010
Start date
Feb 2010
Primary completion
Jun 2013
Completion
Jun 2013
Last update
May 28, 2015

Study contacts

Dr. E.J. Heathcote, MD, FRCP, FRCP(C)
principal investigator · University Health Network - Toronto Western Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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