NCT00282256

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

A Phase 2, Open-Label, Multi-center Study to Assess the Pharmacokinetics, Long-Term Safety and Tolerability of Tacrolimus in Stable Pediatric Liver Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus modified release (MR)	Oral
DRUG	tacrolimus	Oral

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-01-26
• Last updated: 2013-10-17
• Results posted: 2013-10-17

Locations

5 sites across 1 country: United States