Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

• Status: Completed
• Trial end date: 2013-05-03
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

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