Trial information
A Study to Assess the Efficacy and Safety of CellCept (Mycophenolate Mofetil) in Combination With Cyclosporine and Corticosteroids in Preventing Acute Rejection in Pediatric Liver Transplant Patients
Status: Completed
Protocol number: PA16497
Sponsor: Roche Global Development
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of CellCept on the pharmacokinetics of mycophenolic acid in immediate and late post-transplant periods in pediatric liver transplant patients
Brief summary: In the pilot phase of the study, the optimal dose of CellCept in pediatric patients will be determined in stable pediatric liver transplant patients (ie,<=6 months post-transplant) by pharmacokinetic analysis. The efficacy and safety of CellCept in combination with cyclosporine and corticosteroids will then be evaluated in pediatric liver transplant patients, in the confirmatory phase of the study. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
12.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacokinetics study
Condition: Liver Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Pharmacokinetics: Cmax, Tmax, AUC of MPA and MPAG
Key secondary outcomes: 1. Rejection data, AEs, infectious episodes, collection of concomitant medications and immunosuppressive therapies, laboratory abnormalities, patient and graft survival, malignancies
Inclusion criteria:
- male or female patients;
- 3 months to 12 years of age;
- weight >=5 kg (approximately 11 lbs);
- recipient of a first liver transplant;
- single-organ recipient (liver only);
- pilot phase only: at least 6 months post-transplant, receiving stable doses of CellCept, cyclosporine and corticosteroids.
Exclusion criteria:
- pilot phase only: dialysis within 2 weeks before pharmacokinetic sampling;
- confirmatory phase only: concomitant treatment with other investigational drugs or prohibited immunosuppressants;
- confirmatory phase only: inability to start oral CellCept within 72 hours of transplantation surgery.
Gender: Males or Females
Age limits: Min: 3 Months Max: 12 Years
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- San Francisco, CA
- New York, NY
