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

Terminated

• Conditions: Chronic Hepatitis C - Genotype 3

• Registration Number: NCT01100749
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Factors associated with treatment outcome in genotype 3 in CHC	Within 12 weeks before starting treatment compared to end of treatment response	To study how factors such as viral subtype, ethnicity, insulin resistance, IL28 genotype and severity of liver disease contribute to treatment response.

Trial Locations

Locations (2)

University Health Network - Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital - Dr. M. Sherman Liver Clinic; 🇨🇦 Toronto, Ontario, Canada