A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
Completed · Phase 4 · Has a placebo group
Conditions studied: Heart Transplantation
In brief
The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.
Key facts
- Study ID
- NCT00048165
- Run by
- Hoffmann-La Roche
- People needed
- 434
- Starts
- 1999-08-01
- Expected to finish
- 2002-08-01
- Last updated by the study team
- 2016-06-13
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants must be undergoing their first cardiac allograft transplant
- Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation
- Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy
- Participants and/or their guardians must be willing and be capable of understanding risks and comply with the purpose of the study
You may not qualify if…
- Previous organ transplants
- Participants receiving multiple organs
- Participants requiring ventricular assist device (VAD) upon completion of transplantation surgery
- Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study
- History of a psychological illness or condition which would interfere with the participant's ability to understand the requirements of the study
- White blood count =<2500/mm\^3, platelets =<50,000/mm\^3 or hemoglobin =<6 g/dL
- HIV-1, the presence of positive HBsAg, or chronic active hepatitis C
- Active peptic ulcer disease
- Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication
- Malignancies within the past 5 years, excluding skin carcinoma that have been adequately treated
- Participants who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study
- Inability to start microemulsion form of cyclosporine within 72 hours
Where it is running
- Study site — Birmingham, Alabama, United States
- Study site — Los Angeles, California, United States
- Study site — Tampa, Florida, United States
- Study site — Louisville, Kentucky, United States
- Study site — Baltimore, Maryland, United States
- Study site — Boston, Massachusetts, United States
- Study site — Boston, Massachusetts, United States
- Study site — Ann Arbor, Michigan, United States
- Study site — Minneapolis, Minnesota, United States
- Study site — Albuquerque, New Mexico, United States
- Study site — New York, New York, United States
- Study site — Durham, North Carolina, United States
- Study site — Cincinnati, Ohio, United States
- Study site — Cleveland, Ohio, United States
- Study site — Portland, Oregon, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Philadelphia, Pennsylvania, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — Charleston, South Carolina, United States
- Study site — Dallas, Texas, United States
- Study site — Dallas, Texas, United States
- Study site — Houston, Texas, United States
- Study site — Salt Lake City, Utah, United States
- Study site — Madison, Wisconsin, United States
- Study site — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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