Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

NCT00710801 | Completed

• 1 other identifier: COLO400A2427
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus.

Conditions

Hepatitis C Virus

Keywords

Hepatitis C Virus; HCV; Liver Transplant; Cyclosporine; Tacrolimus; Myfortic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCV positive patients undergoing orthotopic liver transplantation

You may qualify if:

• About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
• Willing and capable of giving written consent for study participation
• Expected to be capable of study participation for full 24 months post-transplantation.
• Allograft biopsies will be possible
• Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM

You may not qualify if:

• This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
• This is a liver transplant from a non-heart beating donor.
• This is an ABO incompatible transplant.
• Patients with serum creatinine level \> 250 umol/L.
• The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
• Fulminant liver failure is the reason for transplant.
• Patient is participating in other clinical trial involving exploratory drug
• There is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting Milan criteria for transplantation5.
• The patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
• Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
• A female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
• An unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.

Sponsors & Collaborators

• University of Alberta: lead
• Novartis: collaborator

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Tissue

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew L Mason, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: May 1, 2005
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

CA (1)