Chronic Hepatitis C - Genotype 3NCT01100749
Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada
An observational study of Chronic Hepatitis C - Genotype 3, run by University Health Network, Toronto at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C - Genotype 3
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects across Canada with chronic hepatitis C, genotype 3 infection who are treatment naïve.
Who may be able to join
- Infected with only genotype 3, hepatitis C
- Treatment naïve before current course of therapy
- Age 18 or older
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital - Dr. M. Sherman Liver Clinic
Toronto, Ontario, M5G 2C4
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: Demography, Clinical Characteristics, Metabolic Status, Viral Subtype and Genetics of Infection With Hepatitis C Genotype 3 in Canada
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.
Read the 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
- Keywords
- Hepatitis C, Genotype 3, Demographics, Genetics, Metabolic status
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 weeks before starting treatment compared to end of treatment response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C - Genotype 3Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. E.J. Heathcote, MD, FRCP, FRCP(C), Principal investigator, University Health Network - Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100749
- Sponsor's protocol ID
- Geno3-Demographics Study
- Status last verified
- May 2015
- First submitted
- 7 Apr 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18184194Isharwal 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.
PubMed 19675375
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demography, Clinical Characteristics, Metabolic Status, Viral Subtype and Genetics of Infection With Hepatitis C Genotype 3 in Canada
- ClinicalTrials.gov ID
- NCT01100749
- Acronym / sponsor ID
- Geno3-Demographics Study
- Conditions
- Chronic Hepatitis C - Genotype 3
- Keywords
- Hepatitis C, Genotype 3, Demographics, Genetics, Metabolic status
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects across Canada with chronic hepatitis C, genotype 3 infection who are treatment naïve.
Key inclusion criteria (3 listed)
- Infected with only genotype 3, hepatitis C
- Treatment naïve before current course of therapy
- Age 18 or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors associated with treatment outcome in genotype 3 in CHC
Time frame: 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.
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 18184194Freshwater 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.
- Background: PubMed 19675375Isharwal 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. E.J. Heathcote, MD, FRCP, FRCP(C) principal investigator
University Health Network - Toronto Western Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C - Genotype 3, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with treatment outcome in genotype 3 in CHC (time frame: Within 12 weeks before starting treatment compared to end of treatment response). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100749, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015; AzTrials last refreshed its copy on 3 Nov 2026.