A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplantation
Intervention: Tacrolimus modified-release (Drug); Prograf (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Prof. Leng Xisheng, Principal Investigator, Affiliation: Department of Hepatobiliary surgery
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
Clinical Details
Official title: 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.
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Event rate of patients with acute rejections
Secondary outcome: Incidence of and time to acute rejectionsOverall frequency of acute rejections Rate of patient and graft survival following transplantation.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Beijing, China
Shanghai, China
Guangzhou, Guangdong, China
Tianjin, Tianjing, China
Hangzhou, Zheijiang, China
Additional Information
Starting date: March 2007
Ending date: May 2008
Last updated: April 22, 2008
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