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

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00606528

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

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

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

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

Biospecimen Description:

Whole Blood Plasma Liver tissue from biopsy

Estimated Enrollment:	65
Study Start Date:	February 2008
Estimated Primary Completion Date:	June 2010 (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. 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 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
Coexistence of liver disease of other etiology
evidence of hepatocellular carcinoma
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

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

Contacts

Contact: Jill Sheedy, RN BScN

416-340-4800 ext 4540

jill.sheedy@uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
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:

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.

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. 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.

Responsible Party:	University Health Network ( Dr. Gary Levy )
Study ID Numbers:	07-0841-T
Study First Received:	January 21, 2008
Last Updated:	February 18, 2008
ClinicalTrials.gov Identifier:	NCT00606528
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Antiviral therapy

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Flaviviridae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009