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. In addition to standard treatment, study participants will receive either Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for at least the first 90 days after transplant. The treatment assignment is random and is not chosen by the subjects or their physicians. Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12, following the transplant. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled.

Condition	Intervention
Liver Diseases Transplant Rejection	Drug: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]

Further Study Details: 

Primary Outcomes: This study will evaluate the effect of Thymoglobulin induction therapy on the incidence of liver transplant rejection at 6 months.
Expected Total Enrollment:  75

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
• Serum creatinine > 1.5mg/dL
• 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

Exclusion Criteria:

• 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
• Hepatitis B induced end-stage liver disease
• Donor with positive serology for hepatitis B (including core antibody positive)
• 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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00117689

California
      USC University Hospital, Los Angeles,  California,  90033,  United States; Recruiting
      University of California, San Fransisco Hospital, San Fransisco,  California,  94143,  United States; Recruiting
Colorado
      University of Colorado Hospital and Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
Minnesota
      Fairview University Medical Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Nebraska
      University of Nebraska, Omaha,  Nebraska,  68198,  United States; Recruiting
New York
      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
Ohio
      University of Cincinnati Medical Center, Cincinnati,  Ohio,  45267,  United States; Recruiting
Texas
      University of Texas Health Science Center at San Antonio, University Hospital, San Antonio,  Texas,  78229,  United States; Recruiting
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States; Recruiting
Virginia
      VCU Medical Center, Richmond,  Virginia,  23298,  United States; Recruiting
Canada, Quebec
      Royal Victoria Hospital, Montreal,  Quebec,  H3A 1A1,  Canada; Recruiting

Study ID Numbers:  THYMO102700103
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 7, 2005
ClinicalTrials.gov Identifier:  NCT00117689
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26