A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Daclizumab; Immunoglobulin G; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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