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

Stopped early · Phase 2

Conditions studied: Pediatric Liver Transplantation

In brief

The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept). The second part (open-label, multi-center, single-arm Phase IV study) of the study will provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the immediate post-transplant period. This study will be conducted at two centers based in the United States of America. Twelve pediatric transplant participants receiving a first liver allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric liver transplant participants who are at least 6 months post-transplant and who were already receiving stable dose of MMF in combination with cyclosporine will be enrolled into the study. Participants should have received stable MMF dose according to center practice for at least seven days in order to get steady state pharmacokinetics (PK). Participants also should have received stable concomitant doses of cyclosporine (for at least 2 days) and corticosteroids per center practice. Participants will be aged between 9 months and 12 years, with at least 6 participants greater than or equal to (\>/=) 9 months and less than (\<) 36 months, of whom at least 2 will be \<24 months.

Key facts

Study ID: NCT02630563
Run by: Hoffmann-La Roche
People needed: 9
Starts: 2003-05-01
Expected to finish: 2005-01-01
Last updated by the study team: 2016-05-19

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Pregnant or nursing adolescents
Participants who had undergone dialysis within two weeks before PK sampling
Participants with active systemic infections
Participants with absolute neutrophil counts (ANC) of less than 1300 per microliter (µL), or platelets counts less than 50 000/µL or hemoglobin at a concentration below a set lower limit (according to center practice, but not less than 8 grams per deciliter) at the time of study entry
Participants with active peptic ulcer disease
Participants with severe diarrhea (more than 5 watery stools per day) or other gastrointestinal disorders which might interfere with their ability to absorb oral medication
History of positive human immunodeficiency virus (HIV) test

Where it is running

Study site — San Francisco, California, United States
Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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