Clinical trials: Transplantation, Liver
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, 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
Intraoperative Complications
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven…
- Trial name
- NCT00308100
- Testing
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fresenius Kabi
Hepatic Veno-Occlusive Disease
European VOD Registry
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a…
- Trial name
- NCT03032016
- Where
- 53 sites in France, Italy and 2 more
- Volunteers
- 176 people
- Sponsor
- Jazz Pharmaceuticals
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
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
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure.
- Trial name
- NCT01733082
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Genentech, Inc.
Alcoholic Liver Cirrhosis
Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
- Trial name
- NCT05093881
- Where
- 14 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Pharmicell Co., Ltd.
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Liver Transplantation
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.
- Trial name
- Assign (NCT04761731)
- Testing
- ADVAGRAF®
- Volunteers
- 31 people
- Sponsor
- Linical Korea
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
Hepatitis B
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion…
- Trial name
- NCT01590615
- Testing
- Anti-HBV nucleoside/nucleotide therapy
- Where
- 27 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
Liver Transplantation, Immunosuppression
Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its…
- Trial name
- FEC-TH (NCT01824368)
- Testing
- Extracorporeal Photopheresis Procedure (FEC)
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Red de Terapia Celular
Hepatitis C
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.
- Trial name
- NCT01467505
- Testing
- Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a
- Where
- 22 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cytomegalovirus Infections
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients.
- Trial name
- NCT02062294
- Where
- 3 sites in Switzerland
- Volunteers
- 14 people
- Sponsor
- Hoffmann-La Roche
Liver Cirrhosis
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application.
- Trial name
- NCT01342250
- Testing
- conventional therapy plus low dose hUC-MSCs treatment, conventional therapy plus medium dose hUC-MSCs treatment, conventional therapy plus high dose hUC-MSCs treatment
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Coagulation Defect; Bleeding
Quantra QStat Sample Type Comparison
This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.
- Trial name
- NCT06025708
- Testing
- Diagnostic Test: Quantra QStat Cartridge
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- HemoSonics LLC
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
Liver Transplant
Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients
Patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. This early injury is known as primary graft dysfunction and varies from minor abnormalities to…
- Trial name
- NCT01884038
- Testing
- treprostinil sodium
- Where
- United States
- Sponsor
- United Therapeutics