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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Dysfunction; Rejection, Transplant; Transplantation, Liver

Intervention: Thymoglobulin (Biological); Corticosteroid (Drug); Tacrolimus (Drug); Mycophenolate Mofetil (Drug); Tacrolimus (Drug); Mycophenolate Mofetil (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

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 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.

Clinical Details

Official title: A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Freedom from biopsy-proven acute rejection (including humoral rejection)

Secondary outcome:

Explore the impact of Thymoglobulin on kidney function after transplant

Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 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

- 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)

Locations and Contacts

University of Alabama, Birmingham, Birmingham, Alabama 35294, United States

USC University Hospital, Los Angeles, California 90033, United States

University of California, San Fransisco Hospital, San Francisco, California 94143, United States

University of Colorado Hospital and Health Sciences Center, Denver, Colorado 80262, United States

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States

University of Miami, Miami, Florida 33136, United States

Fairview University Medical Center, Minneapolis, Minnesota 55455, United States

Washington University Medical Center, St. Louis, Missouri 63110, United States

University of Nebraska, Omaha, Nebraska 68198, United States

Mount Sinai Medical Center, New York, New York 10029, United States

University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States

Toronto University Hospital - UHN, Toronto, Ontario M5G 2N2, Canada

Royal Victoria Hospital, Montreal, Quebec H3A 1A1, Canada

Baylor University Medical Center, Dallas, Texas 75246, United States

University of Texas Health Science Center at San Antonio, University Hospital, San Antonio, Texas 78229, United States

VCU Medical Center, Richmond, Virginia 23298, United States

Additional Information

US FDA Approved Full Prescribing Information for Thymoglobulin®

Starting date: April 2005
Last updated: March 17, 2015

Page last updated: August 23, 2015

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