A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
NCT ID: NCT01371344
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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TERMINATED
PHASE4
47 participants
INTERVENTIONAL
2011-06-24
2017-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Part A: Heart Transplant (Tacrolimus granules)
In Part A of the study, participants who are heart transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Tacrolimus granules
oral
Part A: Liver Transplant (Tacrolimus granules)
In Part A of the study, participants who are liver transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Tacrolimus granules
oral
Part A: Kidney Transplant (Tacrolimus granules)
In Part A of the study, participants who are kidney transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Tacrolimus granules
oral
Part B: All Participants (Tacrolimus capsules)
In Part B of the study, participants who are heart, kidney or liver transplant recipients and who are converted from tacrolimus granules-based immunosuppression regimen, receive tacrolimus capsules twice daily for 1 month and thereafter receive commercially available tacrolimus capsules.
Tacrolimus capsules
oral
Interventions
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Tacrolimus granules
oral
Tacrolimus capsules
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject was ≤12 years of age at enrolment into study F506-CL-0403
* Subject received at least one dose of Modigraf in the F506-CL-0403 study
F506-CL-0404 Part B
* Subject received at least one dose of Modigraf in the F506-CL-0403 study
* Subject participated in F506-CL-0404 Part A
* Subject has continuously been dosed with Twice daily (BID) Modigraf since the End of Study Visit for Part A (ESVA) from F506-CL-0404 Part A
* Subject is stable and has had no dose changes in the preceding 2 weeks
Exclusion Criteria
F506-CL-0404 Part B
0 Years
12 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Study Manager
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Site BE40 Clinique Univ. Saint Luc
Brussels, , Belgium
Site FR60 Groupement Hospitalier EST
Bron, , France
Site FR61 Hopital Robert Debre
Paris, , France
Site DE31 Kliniken der Medizinischen Hoc
Hanover, , Germany
Site DE30 Universitätsklin Heidelberg
Heidelberg, , Germany
Site PL50 Centrum Zdrowia Dziecka
Warsaw, , Poland
Site ES22 H.U. Gregorio Maranon
Madrid, , Spain
Site ES20 Hospital Universitario La Paz
Madrid, , Spain
Site ES21 Hospital Universitario La Paz
Madrid, , Spain
Site ES23 Hospital Universitario La Paz
Madrid, , Spain
Site GB14 Alder Hey Children Hospital
Liverpool, , United Kingdom
Site GB13 Cent. Manchester Uni. Hospital
Manchester, , United Kingdom
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2009-012259-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F506-CL-0404
Identifier Type: -
Identifier Source: org_study_id
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