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

Chronic Hepatitis C - Genotype 3 Clinical Trial

Official title:

Demography, Clinical Characteristics, Metabolic Status, Viral Subtype and Genetics of Infection With Hepatitis C Genotype 3 in Canada

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01100749
• Other study ID #: Geno3-Demographics Study
• Status: Terminated
• Phase: N/A
• First received: April 7, 2010
• Last updated: May 27, 2015
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis C - Genotype 3
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Canada	Toronto General Hospital - Dr. M. Sherman Liver Clinic	Toronto	Ontario
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 12 weeks before starting treatment compared to end of treatment response	No