Clareo Health | A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
