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
|Condition or disease|
|Liver Transplantation Hepatitis C|
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|
|Estimated Enrollment :||70 participants|
|Observational Model:||Case Control|
|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|
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
- serum FGL2 levels [ Time Frame: various time points ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT00701272
|Toronto General Hospital (University Health Network)|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Gary Levy, MD||University Health Network, Toronto|