Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

Who is eligible to participate?

Inclusion Criteria: - Written informed consent - Ability and willingness to adhere to study regimen - Completed core study with assigned regimen Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: - Severe hypercholesterolemia or hypertriglyceridemia. - Low platelet count. - Low white blood cell count. - Positive test for human immunodeficiency virus (HIV). - Systemic infection requiring active use of IV antibiotics. - Patients in a critical care setting. - Use of prohibited medication. - Use of immunosuppressive agents not utilized in the protocol. - Hypersensitivity to any of the study drugs or similar drugs. - Pregnant or nursing (lactating) women - Women of child-bearing potential not using a highly effective method of birth control. Other protocol-defined inclusion/exclusion criteria may apply

Last updated:

4/28/2012

NCT ID:

NCT01150097