Clinical trials: Liver Transplant Recipients
Liver Transplant Rejection
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
- Trial name
- CONTRAIL I (NCT03781414)
- Testing
- CFZ533, Tacrolimus - MMF - corticosteroids
- Where
- 29 sites in United States, Argentina and 8 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Trial name
- DIAMOND (NCT01011205)
- Testing
- Advagraf, Mycophenolate Mofetil, Basiliximab
- Where
- 72 sites in Argentina, Austria and 21 more
- Volunteers
- 893 people
- Sponsor
- Astellas Pharma Inc
Liver Transplant
Efficacy and Safety of Once-Daily Tacrolimus in Liver Transplant Recipients (SOUL)
The purpose of this study is to evaluate the efficacy and safety of conversion to TacroBell slow-release cap.(Once-daily Tacrolimus) in patients undergoing maintenance therapy with Twice-Daily Tacrolimus after liver…
- Trial name
- NCT04069065
- Testing
- Conversion to Once-daily Tacrolimus
- Where
- South Korea
- Volunteers
- 146 people
- Sponsor
- Chong Kun Dang Pharmaceutical
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.
Heart Transplantation, Liver Transplantation
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record…
- Conditions
- Heart Transplantation, Liver Transplantation, Kidney Transplantation
- Trial name
- NCT02118896
- Testing
- FK506E
- Where
- 105 sites in United States, Australia and 21 more
- Volunteers
- 850 people
- Sponsor
- Astellas Pharma Europe Ltd.
Liver Transplantation
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
- Trial name
- MAIN (NCT01339468)
- Testing
- Advagraf, Prograf
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related…
- Trial name
- NCT00267189
- Testing
- Everolimus, Calcineurin inhibitors (CNI), Mycophenolate acid (MPA)/ Azathioprine (AZA)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 145 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00405652
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant
Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant…
- Trial name
- NCT00171509
- Testing
- Cyclosporine microemulsion
- Volunteers
- 61 people
- Sponsor
- Novartis
Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM.
- Trial name
- NCT00150085
- Testing
- cyclosporine micro-emulsion
- Volunteers
- 50 people
- Sponsor
- Novartis
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
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to…
- Trial name
- SIMCER (NCT01625377)
- Testing
- tacrolimus, everolimus, Basiliximab
- Where
- 14 sites in France
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
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.
Evidence of Liver Transplantation
Evaluate the Efficacy and Safety of the ADVAGRAF®
The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients.
- Trial name
- STABLE (NCT04763096)
- Testing
- Advagraf
- Where
- South Korea
- Volunteers
- 101 people
- Sponsor
- Linical Korea
Recurrent Hepatitis C
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection
This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant
- Trial name
- REVERT (NCT00582738)
- Testing
- CsA-TAC (standard Treatment), Everolimus
- Where
- Argentina
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis C, HCV
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C…
- Conditions
- Chronic Hepatitis C, HCV, Hepatitis C Virus
- Trial name
- NCT02692703
- Testing
- glecaprevir/pibrentasvir
- Volunteers
- 100 people
- Sponsor
- AbbVie
de Novo Liver Transplant Subjects
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
- Trial name
- Maple (NCT01882322)
- Testing
- Prograf, Advagraf
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Astellas Pharma Korea, Inc.
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.
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals Co., Ltd.