Product Name: CellCept [mycophenolate mofetil]
Date of Report: 11/1/2004
Phase: II
A pilot study of the pharmacokinetics, safety and efficacy of mycophenolate mofetil (CellCept) and sirolimus (Rapamune) in renal transplantation when used in conjunction with daclizumab (Zenapax) and corticosteroids.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 1/26/2005
Phase: III
Two-arm, open-label, randomized, multi-center study of the addition of CellCept (MMF, mycophenolate mofetil) to a tacrolimus-based immunosuppressive regimen for the prevention of acute rejection in hepatic allografts recipients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of the Effect of CellCept (Mycophenolate Mofetil) on Renal Function After Withdrawal of Cyclosporine in Kidney Transplant Patients
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients with Active Pemphigus Vulgaris (PV)
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 7/1/2005
Phase: IV
Open-label, comparative study of daclizumab in combination with mycophenolate mofetil and tacrolimus versus tacrolimus in combination with steroids for the prevention of acute rejection in recipients of allogenic liver transplants.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Kidney Spare the Nephron (STN) study A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
This is an open-label, prospective, randomized, controlled multi-center study assessing fixed dose vs concentration controlled CellCept® regimens for patients following a single organ renal transplantation in combination with full dose and reduced dose calcineurin inhibitors
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Multicenter, prospective, randomized, open-label trial comparing the efficacy and safety of CellCept® with delayed introduction of sirolimus and discontinuation of cyclosporine, to those of standard immunosuppression comprising Cellcept and long-term continuation of cyclosporine in renal transplant recipients receiving an induction by Zenepax® and treated with corticosteroids for 8 months
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A prospective, open-label, multi-center, randomized trial of the efficacy and safety of a long term calcineurin inhibitor free maintenance regimen with mycophenolate mofetil and sirolimus in recipients of an orthotopic liver transplant
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
An open, prospective, randomized, controlled study comparing CellCept® (mycophenolate mofetil, MMF) administered as a component of tacrolimus based immunosuppression therapy, at a loading dose of 3 g daily during the initial post-transplant period versus CellCept® administered at a dose of 2 g daily, in recipients of renal allografts: a multicentre pilot study
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) and Zenapax in Prevention of Acute Rejection in Heart Transplant Patients
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 12/1/2005
Phase: IV
A study of the safety, tolerability and pharmacokinetics of oral CellCept (mycophenolate mofetil, MMF) in pediatric liver transplant recipients on concomitant treatment with Cyclosporine and Corticosteroids.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 5/1/2006
Phase: III
Multicentre, prospective, randomized, controlled, open-label trial evaluating the benefit on renal function of an introduction of CellCept combined with a half-dose of cyclosporine versus a group with usual doses of cyclosporine in renal transplant recipients with altered renal function.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of a Steroid Sparing Regimen in Combination With CellCept, Zenapax and Sirolimus in the Prevention of Acute Renal Allograft Rejection.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: II
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 6/12/2006
Phase: II
An Exploratory Study to Evaluate the Pharmacokinetics, Efficacy, Safety and Tolerability of Mycophenolate Mofetil (CellCept) in Liver Transplant Patients Receiving Standard or Reduced Levels of Tacrolimus (Prograf).
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 8/1/2006
Phase: IV
A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune®) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
A Study of CellCept (Mycophenolate Mofetil) in Management of Patients With Lupus Nephritis.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 10/2/2006
Phase: III
The use of daclizumab (Zenapax) and mycophenolate mofetil (CellCept) in combination with corticosteroids and Neoral (low dose versus low dose followed by complete withdrawal) to optimize renal function in recipients of renal allografts.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched from EC-MPS.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: III
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 4/2/2007
Phase: II
An open, pilot, parallel group, randomized clinical trial to evaluate pharmacokinetic variability of mycophenolate mofetil in association with cyclosporine and corticosteriods administered for 9 months following a dose controlled or a concentration controlled 3 months regimen in primary orthotopic heart transplant recipients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 5/28/2007
Phase: III
A prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: 9/10/2007
Phase: III
An optional continuation of double-blind treatment for patients who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in patients with myasthenia gravis).
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Product Name: CellCept [mycophenolate mofetil]
Date of Report: To be Published
Phase: IV
A Study of CellCept (Mycophenolate Mofetil) Combined WIth Calcineurin Inhibitors in Liver Transplant Patients.
