FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

• Conditions: Liver Transplantation; Hepatitis C

• Registration Number: NCT00701272
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-25
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum FGL2 levels	various time points

Trial Locations

Locations (1)

Toronto General Hospital (University Health Network); 🇨🇦 Toronto, Ontario, Canada