Study Stopped
Due to extremely slow recruitment, infrequent use of combination triple therapy (MMF, cyclosporine, steroids), study was discontinued; Part 2 was not conducted.
Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids
A Study of the Safety, Tolerability and Pharmacokinetics of Oral CellCept® (Mycophenolate Mofetil, MMF) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids
Other study identifiers
Sponsor study identifier
interventional
9
1 country
2
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)Brief Summary
The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is comparable to that achieved in adult liver transplant participants receiving the approved dose of mycophenolate mofetil (MMF, CellCept). The second part (open-label, multi-center, single-arm Phase IV study) of the study will provide the pharmacokinetics, efficacy and safety profile of the proposed dose in the immediate post-transplant period. This study will be conducted at two centers based in the United States of America. Twelve pediatric transplant participants receiving a first liver allograft from a cadaveric or living donor will be enrolled in this study. Stable pediatric liver transplant participants who are at least 6 months post-transplant and who were already receiving stable dose of MMF in combination with cyclosporine will be enrolled into the study. Participants should have received stable MMF dose according to center practice for at least seven days in order to get steady state pharmacokinetics (PK). Participants also should have received stable concomitant doses of cyclosporine (for at least 2 days) and corticosteroids per center practice. Participants will be aged between 9 months and 12 years, with at least 6 participants greater than or equal to (\>/=) 9 months and less than (\<) 36 months, of whom at least 2 will be \<24 months.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- terminated
- Actual enrollment (reported)
- 9 participants
- Study completion date
January 2005
Actual (reported)- Listed locations
- 1 countries · 2 sites
Trial Relationships
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Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2005
Actual (reported)Study Completion
January 2005
Actual (reported)First Submitted
December 11, 2015
Actual (reported)First Posted
December 15, 2015
Actual (reported)Results Posted
April 12, 2016
Actual (reported)
- Last Updated
- May 19, 2016
- Status Verified
- December 2015
- Results QC Date
- March 14, 2016
- Last Update Submitted
- April 19, 2016