A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

Liver Transplantation Clinical Trial

Official title:

A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720408
• Other study ID #: PRGXLLTx-0702-TW
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: September 14, 2009
• Start date: December 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures

• Patient is a primary liver transplant recipient

• Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation

• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a liver

• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)

• Patient has received a liver transplant from a non-heart beating donor

• Patient has received an ABO incompatible donor liver

• Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully

• 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 has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus

• 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, mycophenolate mofetil or corticosteroids

• Patient is pregnant or lactating

• Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies

• Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

Study Design

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

Related Conditions & MeSH terms

• Host vs Graft Reaction
• Liver Transplantation
• Transplantation Immunology

Intervention

Drug:
• Prograf-XL
oral
• Prograf
oral
• MMF
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 (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.		6 month	No
Secondary	Patient and graft survival rates during the 6 and 12 months post-transplant		6 and 12 month	No
Secondary	Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant		12 month	No
Secondary	Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant		6 and 12 month	No