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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00622869 |
This trial is designed to address important issues that impact recipients of liver allografts as well as clinicians, ie. renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in Hepatitis C virus (HCV) positive patients.
Condition | Intervention | Phase |
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Liver Transplantation |
Drug: Everolimus Drug: Tacrolimus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24 Month, Multicenter, Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-Controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients |
Estimated Enrollment: | 690 |
Study Start Date: | January 2008 |
Arms | Assigned Interventions |
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1: Experimental
Tacrolimus elimination arm (low dose tacrolimus until Month 4, then tacrolimus eliminated + everolimus + corticosteroids)
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Drug: Everolimus
Tacrolimus elimination arm (low dose tacrolimus until Month 4, then tacrolimus eliminated + everolimus + corticosteroids)
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3: Active Comparator
Tacrolimus control arm (control dose tacrolimus + corticosteroids)
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Drug: Tacrolimus
Tacrolimus control arm (control dose tacrolimus + corticosteroids)
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2: Active Comparator
Tacrolimus minimization arm (low dose tacrolimus/tacrolimus reduced + everolimus + corticosteroids)
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Drug: Tacrolimus
Tacrolimus minimization arm (low dose tacrolimus/tacrolimus reduced + everolimus + corticosteroids)
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | 41613241111 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CRAD001H2304 |
Study First Received: | February 13, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00622869 |
Health Authority: | Italy: The Italian Medicines Agency; United States: Food and Drug Administration |
Liver transplantation everolimus calcineurin inhibitors tacrolimus |
renal function MDRD formula progression of fibrosis |
Everolimus Fibrosis Disease Progression Tacrolimus |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |