A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
NCT ID: NCT00451932
Last Updated: 2008-04-17
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
303 participants
INTERVENTIONAL
2002-10-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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FK778
Eligibility Criteria
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Inclusion Criteria
* Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
* Male patients must agree to practice effective birth control methods during the study.
* Patient is a recipient of a primary whole cadaveric liver transplant
Exclusion Criteria
* Patient has received an ABO incompatible donor liver.
* Patient or donor is known to be HIV positive.
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
* Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
* Patient who is receiving or may require warfarin or fluvastatin during the study.
* Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Principal Investigators
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Use Central Contact
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinik Charité
Locations
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Innsbruck, , Austria
Brussels, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Brno, , Czechia
Prague, , Czechia
Clichy, , France
Lyon, , France
Montpellier, , France
Rennes, , France
Strasbourg, , France
Villejuif, , France
Berlin, , Germany
Essen, , Germany
Hamburg, , Germany
Hanover, , Germany
Budapest, , Hungary
Milan, , Italy
Udine, , Italy
Rotterdam, , Netherlands
Barakaldo, , Spain
Barcelona, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Zurich, , Switzerland
Birmingham, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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8778-CL-1200
Identifier Type: -
Identifier Source: secondary_id
FG-778-01-100
Identifier Type: -
Identifier Source: org_study_id