NCT00606528

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2008

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

5.4 years

First QC Date

January 21, 2008

Last Update Submit

July 24, 2013

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Antiviral therapy

Outcome Measures

Primary Outcomes (1)

  • correlation between blood FGL2 levels and response to antiviral therapy

    6 months after the end of treatment

Secondary Outcomes (1)

  • correlation between FGL2 levels and Treg percentage in blood and liver cells

    all time points

Study Arms (2)

Group A

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

Other: No intervention

Group B

Healthy volunteers willing to donate blood on 2 separate occasions

Interventions

No interventionOTHER

None. This is an observational study.

Group A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • able to give written consent
  • 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

You may not qualify if:

  • 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)
  • able and willing to provide written informed consent
  • willing to provide a brief review of medical history
  • yrs of age, of either gender
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

  • 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. doi: 10.4049/jimmunol.180.1.249.

    PMID: 18097026BACKGROUND

  • 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. doi: 10.1007/978-0-387-33012-9_76. No abstract available.

    PMID: 17037572BACKGROUND

  • 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. doi: 10.4049/jimmunol.170.8.4036.

    PMID: 12682232BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Plasma Liver tissue from biopsy

Study Officials

  • Gary Levy, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2008

First Posted

February 4, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2013

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

CA(1)