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

NCT ID: NCT01100749

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-06-30

Brief 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.

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.

Conditions

Chronic Hepatitis C - Genotype 3

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. E.J. Heathcote, MD, FRCP, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Toronto Western Hospital

Locations

Toronto General Hospital - Dr. M. Sherman Liver Clinic

Toronto, Ontario, Canada

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 18184194 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19675375 (View on PubMed)

Other Identifiers

Geno3-Demographics Study

Identifier Type: -

Identifier Source: org_study_id