A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplantation
Intervention: Prograf (Drug); Advagraf (Drug); Myfortic (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Summary
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release
tacrolimus with Myfortic® in de novo liver transplant recipients.
Clinical Details
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of biopsy confirmed acute rejection
Secondary outcome: Patient and graft survival ratesTime to first biopsy confirmed acute rejection episode Incidence of anti-lymphocyte antibody therapy for treatment of rejection Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is a primary liver transplant recipient
- 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 has previously received or is receiving an organ transplant other than a
liver
- 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
Locations and Contacts
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Additional Information
Starting date: April 2009
Last updated: October 5, 2011
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