Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

Completed · Phase 2

Conditions studied: Liver Dysfunction, Rejection, Transplant, Transplantation, Liver

In brief

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.

Key facts

Study ID

NCT00117689

Run by

Genzyme, a Sanofi Company

People needed

75

Starts

2005-04-01

Expected to finish

2007-12-01

Last updated by the study team

2015-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
• Serum creatinine > 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation
• Ages greater than or equal to 18 years
• If female, must not be lactating; must have a negative serum beta-human chorionic gonadotropin (HCG) test within 7 days prior to Study Day 0 (Day of Transplant); and must agree to practice an acceptable and reliable form of contraception during the study
• Signed informed consent

You may not qualify if…

• Living donor or multiple organ transplants
• Prior solid organ or bone marrow transplant recipient
• Fulminant hepatic failure
• Status 1 transplants
• ABO incompatible transplants
• Transplants utilizing livers from non heart-beating donors
• Liver transplant candidates with > 6 weeks of analysis
• Donor with positive serology for hepatitis B surface antigen (HBsAg)
• Evidence of human immunodeficiency virus (HIV)
• Autoimmune hepatitis
• History of chronic steroid or immunosuppressant use in the 90 days prior to transplant, except for inhaled corticosteroids to treat asthma
• Recipient of investigational therapy within 90 days prior to transplant procedure
• Known contraindication to administration of rabbit anti-thymocyte globulin
• Acute viral illness
• History of malignancy within 5 years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and/or hepatocellular carcinoma
• Illness other than primary liver disease (e.g. severe ischemic heart disease, left ventricular dysfunction, or pulmonary disease), which, in the opinion of the investigator, may significantly increase the risk of the transplantation procedure
• Current drug and alcohol abuse that, in the opinion of the investigator, puts subjects at risk for poor compliance (no drug test required)

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• USC University Hospital — Los Angeles, California, United States
• University of California, San Fransisco Hospital — San Francisco, California, United States
• University of Colorado Hospital and Health Sciences Center — Denver, Colorado, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Fairview University Medical Center — Minneapolis, Minnesota, United States
• Washington University Medical Center — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas Health Science Center at San Antonio, University Hospital — San Antonio, Texas, United States
• VCU Medical Center — Richmond, Virginia, United States
• Toronto University Hospital - UHN — Toronto, Ontario, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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