NCT00459719

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

April 10, 2007

Last Update Submit

February 23, 2016

Conditions

Liver Transplantation

Keywords

Liver TransplantationTacrolimusMethylprednisolonePrednisolone

Outcome Measures

Primary Outcomes (1)

  • Event rate of patients with acute rejections

    12 Weeks

Secondary Outcomes (3)

  • Incidence of and time to acute rejections

    12 Weeks

  • Overall frequency of acute rejections

    12 Weeks

  • Rate of patient and graft survival following transplantation.

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

In combination with steroids

Drug: Tacrolimus modified-release

2

ACTIVE COMPARATOR

In combination with steroids

Drug: Prograf

Interventions

Tacrolimus modified-releaseDRUG

oral

Also known as: Advagraf, FK506MR, MR4
1
PrografDRUG

oral

Also known as: tacrolimus, FK506
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Beijing, Beijing Municipality, China

Location

Unknown Facility

Guangzhou, Guangdong, China

Location

Unknown Facility

Shanghai, Shanghai Municipality, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

Unknown Facility

Tianjin, China

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Prof. Leng Xisheng

    Department of Hepatobiliary surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

CN(5)