A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation - Tabular View

Tracking Information

First Received Date ^ICMJE

April 10, 2007

Last Updated Date

March 10, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Event rate of patients with acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Event rate of patients with acute rejections with the first 12 weeks following transplantation.

Change History

Complete list of historical versions of study NCT00459719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of and time to acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Overall frequency of acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Rate of patient and graft survival following transplantation. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Incidence of and time to acute rejections within the first 12 weeks.
Overall frequency of acute rejections within the first 12 weeks.
Rate of patient and graft survival following transplantation.

Descriptive Information

Brief Title ^ICMJE

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

Official Title ^ICMJE

A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.

Brief Summary

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Liver Transplantation

Intervention ^ICMJE

Drug: Tacrolimus modified-release
Drug: Prograf

Study Arms / Comparison Groups

Experimental: In combination with steroids
Active Comparator: In combination with steroids

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent with the date of the patient must be obtained.
Patient between 18-70 years of age receiving the primary liver.
Female patients must have a negative pregnancy test prior to the enrolment.
Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

Liver re-transplantation patients or received an organ transplantation other than a liver.
Living-related liver transplantation patient.
Patient has received an AB0 incompatible donor liver.
Patient who needs antibody induction therapy.
Patient with sever infection requiring treatment.
Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00459719

Responsible Party

Director, Astellas Pharma, Inc

Study ID Numbers ^ICMJE

MR4LTxCN01

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Prof. Leng Xisheng

Department of Hepatobiliary surgery

Information Provided By

Astellas Pharma Inc

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP