Trials / Completed

CompletedNCT01339468

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients

Status: Completed
Phase: Phase 4
Study type: Interventional
Enrollment: 100 (actual)

Sponsor: Astellas Pharma Inc · Industry
Sex: All
Age: 20 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Conditions

Liver Transplantation

Interventions

Type	Name	Description
DRUG	Advagraf	oral
DRUG	Prograf	oral
DRUG	Prograf	intravenous

Timeline

Start date: 2011-04-27
Primary completion: 2014-05-27
Completion: 2014-05-27
First posted: 2011-04-20
Last updated: 2017-07-19

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT01339468. Inclusion in this directory is not an endorsement.