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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018914
• Other study ID #: ADVLTx-0901-TW
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2009
• Last updated: January 28, 2016
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Prograf
oral
• Advagraf
oral
• Myfortic
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Taiwan, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy confirmed acute rejection		during the 6 months post-transplant.	No
Secondary	Patient and graft survival rates		during the 6 months post-transplant	No
Secondary	Time to first biopsy confirmed acute rejection episode		during the 6 months post-transplant	No
Secondary	Incidence of anti-lymphocyte antibody therapy for treatment of rejection		during the 6 months post-transplant.	No
Secondary	Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs		throughout the study	Yes

External Links

•   Link to results on Astellas Clinical Study Results Web site