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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 rates

Time 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

Page last updated: August 23, 2015

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