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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00606528 |
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Date of registration:
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21/01/2008 |
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Primary sponsor: |
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Public title:
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FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
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Scientific title:
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FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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65 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00606528 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Canada
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Contacts
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Name:
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Gary Levy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto |
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Key inclusion & exclusion criteria
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HCV patient population
Inclusion Criteria:
- able to give written consent
- 18-70 yrs of age, both genders
- willing to use adequate contraception
- diagnosis of chronic HCV infection (of any genotype) based on 2 positive serology
tests
- availability of pre- and post-treatment viral load data
- naive to antiviral treatment
- availability of pre-treatment liver biopsy
Exclusion Criteria:
- less than 18 yrs, greater than 70 yrs of age
- pregnancy
- HBV, HDV, or HIV co-infection
- any history of active alcohol or drug abuse
Volunteer Population (Control)
Inclusion Criteria:
- able and willing to provide written informed consent
- willing to provide a brief review of medical history
- 18-70 yrs of age, of either gender
Exclusion Criteria:
- less than 18, greater than 70 yrs of age
- any history of liver, renal, lung, hematological or coronary artery disease
- any history of active alcohol or drug abuse
- any previous diagnosis of HBV, HCV, HDV or HIV
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C Virus Infection
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Intervention(s)
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Other: No intervention
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Primary Outcome(s)
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correlation between blood FGL2 levels and response to antiviral therapy
[Time Frame: 6 months after the end of treatment]
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Secondary Outcome(s)
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correlation between FGL2 levels and Treg percentage in blood and liver cells
[Time Frame: all time points]
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Secondary ID(s)
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07-0841-T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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