FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
The main objective of this study is to assess whether a recently-developed bioassay for the protein FGL2 can be used to predict the progression and/or response to treatment of Hepatitis C Virus disease in patients with chronic HCV infection. The hypothesis is that increased levels of FGL2 and increased numbers of T regulatory cells are associated with a failure to respond to treatment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy|
- correlation between blood FGL2 levels and response to antiviral therapy [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: No ]
- correlation between FGL2 levels and Treg percentage in blood and liver cells [ Time Frame: all time points ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole Blood Plasma Liver tissue from biopsy
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy
Other: No intervention
None. This is an observational study.
Healthy volunteers willing to donate blood on 2 separate occasions
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.
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Gary Levy, MD||University Health Network, Toronto|