Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02630563 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT02630563: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT02630563 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02630563, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study 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.
Primary Outcome
The area under the plasma concentration-time curve from time zero to twelve hours (AUC \[0-12h\]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0
Interventions
- DRUG Cyclosporine
- DRUG Corticosteroids
- DRUG mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-01 |
| Phase | Phase 2 |
Why NCT02630563 stopped before completion
NCT02630563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclosporine is the first listed.
NCT02630563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02630563 about?
NCT02630563 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids". 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 recei...
What is the current status of trial NCT02630563?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2003-05. Estimated completion is 2005-01.
What interventions are being tested in trial NCT02630563?
The interventions under investigation include: Cyclosporine (DRUG), Corticosteroids (DRUG), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT02630563?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02630563's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia