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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00118742 |
This 2 arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either Cellcept 1-1.5g bid + tacrolimus + cyclosporine or Cellcept 1-1.5 g bid + sirolimus.The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
---|---|---|
Liver Transplantation |
Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine Drug: Sirolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label Study of the Effect of a Long-Term Calcineurin Inhibitor-Free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant |
Enrollment: | 294 |
Study Start Date: | August 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: mycophenolate mofetil [CellCept]
1-1.5g po bid
Drug: Sirolimus
As prescribed
|
2: Active Comparator |
Drug: mycophenolate mofetil [CellCept]
1-1.5g po bid
Drug: Tacrolimus
As prescribed
Drug: Cyclosporine
As prescribed
|
Ages Eligible for Study: | 18 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML18423 |
Study First Received: | June 30, 2005 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00118742 |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Cyclosporine Clotrimazole Miconazole Tioconazole |
Mycophenolic Acid Mycophenolate mofetil Tacrolimus Cyclosporins |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |