Overview

A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
0
Participant gender:
All
Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Tacrolimus
Criteria
Inclusion Criteria:

- Patient is currently receiving Prograf® based immunosuppressive therapy for liver
transplantation.

- Patient has stable whole blood trough level concentrations of Prograf® and is
clinically stable

Exclusion Criteria:

- Patient has previously received an organ transplant other than a liver

- Patient is currently receiving sirolimus immunosuppression therapy.