Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids

Inclusion Criteria

• •Male or female participant must be between 3 months and 12 years of age
• •Participant is a recipient of a first liver allograft from cadaveric or living donors
• •Participant is a single-organ recipient (liver only)
• •Female participants of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli International Units per milliliter (mIU/mL) within one week prior to PK sampling
• •Female participants of childbearing potential must use two reliable forms of contraception simultaneously unless abstinence is the chosen method
• •Effective contraception must be used before beginning of PK sampling
• •Participants must be able to receive oral medication
• •Participants must be at least 6 months post-transplant and had started on MMF in the early post-transplant period (within 2 weeks of transplant)
• •Participants must be receiving stable doses of MMF per center practice for at least 7 days prior to PK sampling
• •In addition, participants must be receiving stable doses of cyclosporine and corticosteroids, according to center practice
• •Participants' parent/guardian are capable of understanding the purposes and risks of the study and must sign an informed consent for the study