FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00701272
First received: June 18, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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
Liver Transplantation
Hepatitis C

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • serum FGL2 levels [ Time Frame: various time points ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples; liver biopsy tissue


Estimated Enrollment: 70
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)
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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701272

Locations
Canada, Ontario
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Gary Levy, MD University Health Network, Toronto
  More Information

Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00701272     History of Changes
Other Study ID Numbers: 08-0385-T
Study First Received: June 18, 2008
Last Updated: July 24, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Recurrence
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014