Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation

Novartis

Status and phase: Completed; Phase 1

Conditions: de Novo Liver Transplantation

Treatments: Drug: AEB071

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545259

CAEB071B2101

Details and patient eligibility

About

The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary liver transplant recipients.
• Transplanted liver functioning at an acceptable level by 24 h post-transplant
• Patients started on tacrolimus therapy within 12 h post-transplant

Exclusion criteria

• Previous transplantation or multiple organs transplantation
• Acute rejection
• Non-heart beating donor

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Description:

AEB071

Treatment:

Drug: AEB071