Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
NCT ID: NCT01011205
Last Updated: 2024-11-01
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
PHASE3
893 participants
INTERVENTIONAL
2009-09-30
2013-01-04
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
TREATMENT
NONE
Study Groups
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Dosing Regimen 1
Advagraf + MMF + Corticosteroids (Bolus)
Advagraf
Capsule
Mycophenolate Mofetil
Solution for infusion
Corticosteroids
IV bolus
Dosing Regimen 2
Advagraf + MMF + Basiliximab + Corticosteroids (Bolus)
Advagraf
Capsule
Mycophenolate Mofetil
Solution for infusion
Basiliximab
IV infusion
Corticosteroids
IV bolus
Dosing Regimen 3
Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus)
Advagraf
Capsule
Mycophenolate Mofetil
Solution for infusion
Basiliximab
IV infusion
Corticosteroids
IV bolus
Interventions
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Advagraf
Capsule
Mycophenolate Mofetil
Solution for infusion
Basiliximab
IV infusion
Corticosteroids
IV bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Exclusion Criteria
* Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
* Receiving ABO incompatible graft or a graft from a non heart beating donor
* Ongoing dosing with systemic corticosteroids
* Subjects with systemic infection requiring treatment except viral hepatitis
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
* \< 3 nodes
* no node larger than 5 cm
* no metastases
* no vascular tumoral invasion
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
* Pregnant woman or breast-feeding mother
* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Unlikely to comply with the Visits scheduled in the protocol
* Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
* Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Global Development - EU
Locations
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160
Buenos Aires, , Argentina
001
Innsbruck, , Austria
146
Minsk, , Belarus
008
Brussels, , Belgium
006
Ghent, , Belgium
009
Leuven, , Belgium
010
Liège, , Belgium
163
São Paulo, , Brazil
153
Edmonton, , Canada
150
Halifax, , Canada
151
London, , Canada
152
Montreal, , Canada
154
Vancouver, , Canada
169
Bogata, , Colombia
147
Prague, , Czechia
026
Helsinki, , Finland
041
Besançon, , France
157
Bordeaux, , France
043
Caen, , France
031
Créteil, , France
039
Lyon, , France
045
Marseille, , France
158
Montpelier, , France
037
Nice, , France
042
Paris, , France
044
Paris, , France
035
Paris, , France
038
Strasbourg, , France
033
Toulouse, , France
034
Villejuif, , France
056
Berlin, , Germany
058
Erlangen, , Germany
051
Frankfurt, , Germany
055
Göttingen, , Germany
057
Hanover, , Germany
142
Jena, , Germany
053
Kiel, , Germany
054
Leipzig, , Germany
Site: 156
Mainz, , Germany
052
Münster, , Germany
060
Regensberg, , Germany
059
Tübingen, , Germany
061
Budapest, , Hungary
070
Dublin, , Ireland
073
Bergamo, , Italy
075
Bologna, , Italy
076
Genova, , Italy
077
Naples, , Italy
079
Naples, , Italy
072
Padua, , Italy
074
Rome, , Italy
071
Udine, , Italy
Site: 166
Mexico City, , Mexico
086
Warsaw, , Poland
087
Warsaw, , Poland
091
Bucharest, , Romania
096
Moscow, , Russia
097
Moscow, , Russia
148
Johannesburg, , South Africa
114
A Coruña, , Spain
109
Barcelona, , Spain
106
Barcelona, , Spain
110
Barcelona, , Spain
115
Madrid, , Spain
108
Madrid, , Spain
117
Madrid, , Spain
116
Zaragoza, , Spain
126
Gothenberg, , Sweden
131
Zurich, , Switzerland
136
Birmingham, , United Kingdom
171
Leeds, , United Kingdom
138
London, , United Kingdom
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2008-002231-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2010-021075-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PMR-EC-1106
Identifier Type: -
Identifier Source: org_study_id
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