FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation
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.
|Study Design:||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|
- serum FGL2 levels [ Time Frame: various time points ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples; liver biopsy tissue
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients undergoing liver transplant for end-stage liver disease due to Hepatitis C
Patients undergoing liver transplantation for end-stage liver disease due to alcoholic cirrhosis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701272
|Toronto General Hospital (University Health Network)|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Gary Levy, MD||University Health Network, Toronto|