Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Pharmacokinetics

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 3 Years Max: 12 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:17:20 PM