Clinical trials: Pediatric Liver Transplant Recipients
Liver Transplantation, Kidney Transplantation
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or…
- Trial name
- NCT05152628
- Testing
- Tacrolimus granules
- Where
- 4 sites in China
- Volunteers
- 55 people
- Sponsor
- Astellas Pharma China, Inc.
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation, Kidney Transplantation
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
- Trial name
- NCT05153915
- Testing
- Tacrolimus granules
- Where
- 7 sites in China
- Volunteers
- 56 people
- Sponsor
- Astellas Pharma China, Inc.
Pediatric Liver Transplantation
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…
- Trial name
- NCT02630563
- Testing
- Corticosteroids, Cyclosporine, mycophenolate mofetil
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Hoffmann-La Roche
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.