Status:
COMPLETED
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Liver Dysfunction
Rejection, Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00117689
Start Date
April 1 2005
End Date
December 1 2007
Last Update
March 18 2015
Active Locations (16)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
USC University Hospital
Los Angeles, California, United States, 90033
3
University of California, San Fransisco Hospital
San Francisco, California, United States, 94143
4
University of Colorado Hospital and Health Sciences Center
Denver, Colorado, United States, 80262