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

University Health Network, Toronto

Status: Completed

Conditions: Chronic Hepatitis C Virus Infection

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT00606528

07-0841-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

54 participants in 2 patient groups

Group A

Description:

patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy

Treatment:

Other: No intervention

Group B

Description:

Healthy volunteers willing to donate blood on 2 separate occasions