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.