A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

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”

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

Intervention(s) in this Clinical Trial

• Drug: Prograf
  • oral
• Drug: Advagraf
  • oral
• Drug: Myfortic
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Prograf with Myfortic
• Experimental: Advagraf with Myfortic

Primary Measures

• Incidence of biopsy confirmed acute rejection
  • Time Frame: during the 6 months post-transplant.
    Safety Issue?: No

Secondary Measures

• Patient and graft survival rates
  • Time Frame: during the 6 months post-transplant
    Safety Issue?: No
• Time to first biopsy confirmed acute rejection episode
  • Time Frame: during the 6 months post-transplant
    Safety Issue?: No
• Incidence of anti-lymphocyte antibody therapy for treatment of rejection
  • Time Frame: during the 6 months post-transplant.
    Safety Issue?: No
• Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
  • Time Frame: throughout the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018914

Study ID Number: ADVLTx-0901-TW

ClinicalTrials.gov Identifier: NCT01018914

Health Authority: Taiwan: Department of Health