Trial information
A Study of CellCept (Mycophenolate Mofetil) in Liver Transplant Patients
Status: Completed
Protocol number: PA16522
Sponsor: Roche Global Development
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of CellCept on the pharmacokinetics of tacrolimus and clinical outcome in liver transplant patients
Brief summary: This study will evaluate the pharmacokinetics, efficacy and safety of CellCept in liver transplant patients currently receiving tacrolimus. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 60.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
Condition: Liver Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Pharmacokinetics: MPA and MPAG plasma and urine concentrations
Efficacy: Biopsy-proven acute rejection or graft loss by week 26 post-transplant
Key secondary outcomes: 1. Safety: Laboratory safety tests, rejection data, graft and patient survival, AEs
Efficacy: Biopsy-proven acute rejection or graft loss by week 52 post-transplant. Time to first biopsy-proven acute rejection
Inclusion criteria:
- adult patients >=18 years of age;
- first orthotopic liver transplant;
- single organ transplant;
- patients of child-bearing potential must be willing to use 2 forms of contraception from the beginning of the trial to 6 weeks after completion of dosing.
Exclusion criteria:
- previous organ transplant;
- positive HIV test result;
- concomitant treatment with another investigational drug or with a prohibited immunosuppressive agent;
- dialysis within 30 days prior to transplantation;
- history of malignancy other than adequately-treated skin melanoma.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Canada
France
Germany
Spain
Switzerland
United Kingdom
