Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
NCT ID: NCT00295607
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2005-06-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Tacrolimus
immunosuppression
steroids, monoclonal anti-IL2R antibody
immunosuppression
2
Tacrolimus
immunosuppression
Interventions
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Tacrolimus
immunosuppression
steroids, monoclonal anti-IL2R antibody
immunosuppression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients receiving a cadaveric liver transplant with compatible ABO blood type can be included.
Exclusion Criteria
* Recipient of an auxiliary graft
* Patient is receiving ABO incompatible graft
* Patients requiring immunosuppressive treatment
* Patients requiring ongoing corticosteroid therapy.
* Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
* Patient or donor is known to be HIV positive.
* Patient is allergic or intolerant to study medication
* Patient is pregnant or breast-feeding.
* Patient has been previously enrolled in this study
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Physician
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Prague, , Czechia
Besançon, , France
Lyon, , France
Nice, , France
Villejuif, , France
Berlin, , Germany
Hamburg, , Germany
Mainz, , Germany
Bologna, , Italy
Genova, , Italy
Modena, , Italy
Warsaw, , Poland
Barakaldo, , Spain
Madrid, , Spain
Santiago, , Spain
Gothenburg, , Sweden
London, , United Kingdom
Countries
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Related Links
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Link to FDA Website
Other Identifiers
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FG-506-01-28
Identifier Type: -
Identifier Source: org_study_id
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