A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

• Status: Terminated
• Trial end date: 2017-04-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

F506-CL-0404 Part A

• 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 A

• As all subjects included in this study conform to the exclusion criteria in study F506-CL-0403, hence no specific exclusion criteria are relevant for this study

F506-CL-0404 Part B

• There are no specific exclusion criteria for this study