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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00606528
First received: January 21, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Chronic Hepatitis C Virus Infection
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • correlation between blood FGL2 levels and response to antiviral therapy [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 54
Study Start Date: February 2008
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy
Other: No intervention
None. This is an observational study.
Group B
Healthy volunteers willing to donate blood on 2 separate occasions

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Chronic HCV treatment-naive patients who are willing to begin antiviral therapy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606528

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Gary Levy, MD University Health Network, Toronto
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00606528     History of Changes
Other Study ID Numbers: 07-0841-T
Study First Received: January 21, 2008
Last Updated: July 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014