- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606528
FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current therapy for chronic Hepatitis C Virus infection leads to a sustained viral response in only 50% of treated patients. Evidence suggests that a poor response to treatment may be the result of a dysfunction of immunoregulatory mediators including T regulatory cells (Tregs) which secrete FGL2. The aim of this study is to test whether serum FGL2 levels can serve as a biomarker for clinical progress and treatment response in patients undergoing anti-viral therapy for chronic HCV infection.
This study will measure the blood Treg and FGL2 levels of patients with chronic Hepatitis C as they undergo antiviral therapy and will compare those levels to their pre-treatment and post-treatment levels. Treg and FGL2 expression levels will also be measured in patients' liver biopsy tissue when available.
Additionally, this study will examine the main form(s)of Fc Receptor expressed in these patients. The Fc receptor is the hypothesized binding partner of FGL2, and the form expressed in a given patient may determine the downstream effects of FGL2's binding. These data along with clinical, biochemical and virological data will be used to determine whether there is a correlation between FGL2 levels and disease outcome and/or treatment response.
The study will also recruit a group of normal healthy volunteers to give blood samples on two occasions so that the baseline range of FGL2 levels in healthy individuals can be established for comparison.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy
|
None.
This is an observational study.
|
Group B
Healthy volunteers willing to donate blood on 2 separate occasions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between blood FGL2 levels and response to antiviral therapy
Time Frame: 6 months after the end of treatment
|
6 months after the end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation between FGL2 levels and Treg percentage in blood and liver cells
Time Frame: all time points
|
all time points
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gary Levy, MD, University Health Network, Toronto
Publications and helpful links
General Publications
- Shalev I, Liu H, Koscik C, Bartczak A, Javadi M, Wong KM, Maknojia A, He W, Liu MF, Diao J, Winter E, Manuel J, McCarthy D, Cattral M, Gommerman J, Clark DA, Phillips MJ, Gorczynski RR, Zhang L, Downey G, Grant D, Cybulsky MI, Levy G. Targeted deletion of fgl2 leads to impaired regulatory T cell activity and development of autoimmune glomerulonephritis. J Immunol. 2008 Jan 1;180(1):249-60. doi: 10.4049/jimmunol.180.1.249.
- Liu H, Zhang L, Cybulsky M, Gorczynski R, Crookshank J, Manuel J, Grant D, Levy G. Identification of the receptor for FGL2 and implications for susceptibility to mouse hepatitis virus (MHV-3)-induced fulminant hepatitis. Adv Exp Med Biol. 2006;581:421-5. doi: 10.1007/978-0-387-33012-9_76. No abstract available.
- Chan CW, Kay LS, Khadaroo RG, Chan MW, Lakatoo S, Young KJ, Zhang L, Gorczynski RM, Cattral M, Rotstein O, Levy GA. Soluble fibrinogen-like protein 2/fibroleukin exhibits immunosuppressive properties: suppressing T cell proliferation and inhibiting maturation of bone marrow-derived dendritic cells. J Immunol. 2003 Apr 15;170(8):4036-44. doi: 10.4049/jimmunol.170.8.4036.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Infections
- Communicable Diseases
- Hepatitis
- Hepatitis A
- Hepatitis C
- Virus Diseases
- Hepatitis C, Chronic
Other Study ID Numbers
- 07-0841-T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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