- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01018914
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
January 28, 2016 updated by: Astellas Pharma Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Prograf with Myfortic
|
oral
Other Names:
oral
Other Names:
|
Experimental: Advagraf with Myfortic
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oral
Other Names:
oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of biopsy confirmed acute rejection
Time Frame: during the 6 months post-transplant.
|
during the 6 months post-transplant.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient and graft survival rates
Time Frame: during the 6 months post-transplant
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during the 6 months post-transplant
|
Time to first biopsy confirmed acute rejection episode
Time Frame: during the 6 months post-transplant
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during the 6 months post-transplant
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Incidence of anti-lymphocyte antibody therapy for treatment of rejection
Time Frame: during the 6 months post-transplant.
|
during the 6 months post-transplant.
|
Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs
Time Frame: throughout the study
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throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 23, 2009
First Submitted That Met QC Criteria
November 23, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
January 29, 2016
Last Update Submitted That Met QC Criteria
January 28, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- ADVLTx-0901-TW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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