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Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Study:

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

Rationale:

n/a

Purpose:

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.

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Liver Transplantation Drug: Everolimus
Drug: Tacrolimus
Drug: Tacrolimus
Phase 3

Verified by Novartis June, 2011

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov identifier: NCT00622869

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Novartis., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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