Clinical trial NCT01100749: Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada
Official title: Demography, Clinical Characteristics, Metabolic Status, Viral Subtype and Genetics of Infection With Hepatitis C Genotype 3 in Canada
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Hepatitis C - Genotype 3
Keywords: Hepatitis C
Genotype 3
Demographics
Genetics
Metabolic status
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects across Canada with chronic hepatitis C, genotype 3 infection who are treatment naïve.

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.

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

Primary outcomes:
measure: Factors associated with treatment outcome in genotype 3 in CHC
timeFrame: Within 12 weeks before starting treatment compared to end of treatment response
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital - Dr. M. Sherman Liver Clinic
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network - Toronto Western Hospital
name: Dr. E.J. Heathcote, MD, FRCP, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.