NCT00701272

Brief Summary

The main objective of this study is to assess whether a recently-developed bioassay for the molecule "secreted fibrinogen-like protein 2" (sFGL2) can be used to predict the recurrence and/or progression of Hepatitis C Virus disease in post liver transplant patients. The hypothesis is that patients with chronic HCV have higher than normal levels of sFGL2 in their blood both pre- and post-transplantation and that this will inhibit their ability to clear HCV, and influence the progression of HCV disease when it recurs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 25, 2013

Status Verified

July 1, 2013

Enrollment Period

6.5 years

First QC Date

June 18, 2008

Last Update Submit

July 24, 2013

Conditions

Liver TransplantationHepatitis C

Outcome Measures

Primary Outcomes (1)

  • serum FGL2 levels

    various time points

Study Arms (2)

1

Patients undergoing liver transplant for end-stage liver disease due to Hepatitis C

2

Control population: Patients undergoing liver transplantation for end-stage liver disease due to alcoholic cirrhosis

Eligibility Criteria

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

Individuals undergoing liver transplantation due to end-stage liver disease caused by Hepatitis C Virus or alcoholic cirrhosis

You may qualify if:

  • Able and willing to give written informed consent
  • Willing to follow the study protocol
  • Diagnosis of chronic HCV infection based on two positive serology tests
  • No history of active alcohol or drug abuse
  • All six viral genotypes are considered
  • Pre- and post transplant viral load data must be available

You may not qualify if:

  • Pregnancy
  • HBV, HDV or HIV co-infection
  • For Non-HCV subjects:
  • Able and willing to give written informed consent
  • Willing to follow the study protocol
  • \. Free from infection by any of the following: HCV, HBV, HDV or HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital (University Health Network)

Toronto, Ontario, M5G 2N2, 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

Blood samples; liver biopsy tissue

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Gary Levy, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 25, 2013

Record last verified: 2013-07

Locations

CA(1)