A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
NCT ID: NCT01018914
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2009-04-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prograf with Myfortic
Prograf
oral
Myfortic
oral
Advagraf with Myfortic
Advagraf
oral
Myfortic
oral
Interventions
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Prograf
oral
Advagraf
oral
Myfortic
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
* Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
* Patient must receive 1st dose of study drug within 24 hours of pre-transplantation
Exclusion Criteria
* Patient currently requires dialysis
* Patient has received a liver transplant from a non-heart beating donor
* Patient has received an ABO incompatible donor liver
* Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
* Patient has fulminant hepatic failure, unless hemodynamically stable
* Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
* Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
* Patient is pregnant or lactating
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Countries
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Related Links
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Link to results on Astellas Clinical Study Results Web site
Other Identifiers
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ADVLTx-0901-TW
Identifier Type: -
Identifier Source: org_study_id
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