Status:
COMPLETED
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.
Eligibility Criteria
Inclusion
- Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
- Patients who need liver transplantation due to the end-stage liver failure
Exclusion
- Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
- Patients receiving auxiliary graft or in whom a bio-artificial
- Patients allergic to macrolide antibiotics or tacrolimus
- Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
- Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
- Patients with systemic infection requiring treatment, except viral hepatitis
- Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with serum creatinine \> 1.5mg/Dl
- Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
- Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
- Patients who are pregnant or breast-feeding mother
- Patients or donors known to be HIV positive
- Patients unlikely to comply with the visits scheduled in the protocol
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00719745
Start Date
February 1 2006
End Date
June 1 2008
Last Update
July 22 2008
Active Locations (1)
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1
Seoul, South Korea