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

This study has been terminated.
(Low recruitment)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01100749
First received: April 7, 2010
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition
Chronic Hepatitis C - Genotype 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Demography, Clinical Characteristics, Metabolic Status, Viral Subtype and Genetics of Infection With Hepatitis C Genotype 3 in Canada

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Factors associated with treatment outcome in genotype 3 in CHC [ Time Frame: Within 12 weeks before starting treatment compared to end of treatment response ] [ Designated as safety issue: No ]
    To study how factors such as viral subtype, ethnicity, insulin resistance, IL28 genotype and severity of liver disease contribute to treatment response.


Biospecimen Retention:   Samples With DNA

Saliva samples will be collected for DNA extraction. Also, blood specimens will be collected for genotype subtype analysis and HOMA score calculation.


Enrollment: 25
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100749

Locations
Canada, Ontario
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Toronto General Hospital - Dr. M. Sherman Liver Clinic
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Dr. E.J. Heathcote, MD, FRCP, FRCP(C) University Health Network - Toronto Western Hospital
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01100749     History of Changes
Other Study ID Numbers: Geno3-Demographics Study
Study First Received: April 7, 2010
Last Updated: July 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Hepatitis C
Genotype 3
Demographics
Genetics
Metabolic status

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014