Status:
COMPLETED
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00459719
Start Date
March 1 2007
End Date
March 1 2009
Last Update
February 24 2016
Active Locations (5)
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1
Beijing, Beijing Municipality, China
2
Guangzhou, Guangdong, China
3
Shanghai, Shanghai Municipality, China
4
Hangzhou, Zhejiang, China