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FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00701272
Recruitment Status : Unknown
Verified July 2013 by University Health Network, Toronto.
Recruitment status was:  Enrolling by invitation
First Posted : June 19, 2008
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date June 18, 2008
First Posted Date June 19, 2008
Last Update Posted Date July 25, 2013
Study Start Date June 2008
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2008)
serum FGL2 levels [ Time Frame: various time points ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation
Official Title FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of HCV Recurrence and Progression Post Liver Transplantation
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.
Detailed Description

Hepatitis C Virus infection (HCV) is a serious health problem worldwide, accounting for significant morbidity and mortality. The current treatment, combination therapy with pegylated IFNa/ribavirin results in only a 50% sustained viral response such that HCV is now the leading indication for liver transplantation. Unfortunately, HCV recurrence post-transplantation is universal and it is often difficult to distinguish recurrent HCV from other processes such as rejection, leading to inappropriate or delayed treatment(s) and compounding graft damage. It would be beneficial to have access to a circulating biomarker to distinguish HCV disease recurrence from other processes and to predict the severity of HCV disease progression post-transplantation.

The molecule FGL2 is secreted by cells of the immune system and may be a key immunomodulator affecting graft survival and HCV recurrence. The aim of this study is to assess whether a bioassay for FGL2 can predict HCV disease recurrence and progression after liver transplantation and/or differentiate HCV disease recurrence from acute cellular rejection.

This study will also examine the form of Fc Receptor expressed in these patients. The Fc receptor is hypothesized to be the binding partner of FGL2.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples; liver biopsy tissue
Sampling Method Non-Probability Sample
Study Population Individuals undergoing liver transplantation due to end-stage liver disease caused by Hepatitis C Virus or alcoholic cirrhosis
Condition
  • Liver Transplantation
  • Hepatitis C
Intervention Not Provided
Study Groups/Cohorts
  • 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

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 18, 2008)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

For HCV positive subjects:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy
  2. HBV, HDV or HIV co-infection

For Non-HCV subjects:

Inclusion Criteria:

  1. Able and willing to give written informed consent
  2. Willing to follow the study protocol

Exclusion Criteria:

1. Free from infection by any of the following: HCV, HBV, HDV or HIV.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00701272
Other Study ID Numbers 08-0385-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Gary Levy, MD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date July 2013