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FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT00606528
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date January 21, 2008
First Posted Date February 4, 2008
Last Update Posted Date July 25, 2013
Study Start Date February 2008
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2008)
correlation between blood FGL2 levels and response to antiviral therapy [ Time Frame: 6 months after the end of treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 21, 2008)
correlation between FGL2 levels and Treg percentage in blood and liver cells [ Time Frame: all time points ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
Official Title FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
Brief Summary 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood Plasma Liver tissue from biopsy
Sampling Method Non-Probability Sample
Study Population Chronic HCV treatment-naive patients who are willing to begin antiviral therapy
Condition Chronic Hepatitis C Virus Infection
Intervention Other: No intervention
None. This is an observational study.
Study Groups/Cohorts
  • Group A
    patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy
    Intervention: Other: No intervention
  • Group B
    Healthy volunteers willing to donate blood on 2 separate occasions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 24, 2013)
54
Original Estimated Enrollment
 (submitted: January 21, 2008)
65
Study Completion Date Not Provided
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00606528
Other Study ID Numbers 07-0841-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Gary Levy, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date July 2013