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FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease
Liver Transplantation Hepatitis C

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of HCV Recurrence and Progression Post Liver Transplantation
Study Start Date : June 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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

Control population:

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

Primary Outcome Measures :
  1. serum FGL2 levels [ Time Frame: various time points ]

Biospecimen Retention:   Samples With DNA
Blood samples; liver biopsy tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701272

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Canada, Ontario
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Gary Levy, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT00701272    
Other Study ID Numbers: 08-0385-T
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes