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

Novartis

Status and phase: Completed; Phase 3

Conditions: Liver Transplant Recipient

Treatments: Drug: Tacrolimus (tacrolimus control); Drug: Corticosteroids; Drug: Everolimus (tacrolimus elimination); Drug: Tacrolimus (tacrolimus elimination); Drug: Everolimus (reduced tacrolimus); Drug: Tacrolimus (reduced tacrolimus)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01150097

2009-017311-15

CRAD001H2304E1

Details and patient eligibility

About

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).

Enrollment: 284 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 3 patient groups

Everolimus + reduced tacrolimus

Experimental group

Description:

Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.

Treatment:

Drug: Tacrolimus (reduced tacrolimus)

Drug: Everolimus (reduced tacrolimus)

Drug: Corticosteroids

Tacrolimus elimination

Experimental group

Description:

Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.

Treatment:

Drug: Everolimus (tacrolimus elimination)

Drug: Tacrolimus (tacrolimus elimination)

Drug: Corticosteroids

Tacrolimus control

Active Comparator group

Description:

Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.

Treatment:

Drug: Corticosteroids

Drug: Tacrolimus (tacrolimus control)