Clinical trials: Transplantation, Liver
Transplantation
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.
- Trial name
- NCT00384202
- Testing
- Tacrolimus
- Where
- 13 sites in France, Germany and 4 more
- Volunteers
- 112 people
- Sponsor
- Astellas Pharma Inc
Ischemia Reperfusion Injury
YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation
The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft directly ex vivo via the portal…
- Trial name
- YSPSL (NCT00876902)
- Testing
- recombinant P-selectin glycoprotein ligand Ig fusion protein, Viaspan® and saline
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Y's Therapeutics, Inc.
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
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the…
- Trial name
- NCT01938625
- Testing
- Simeprevir, Daclatasvir, Ribavirin
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 35 people
- Sponsor
- Janssen R&D Ireland
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Liver Transplantation, Hepatitis
Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
- Conditions
- Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
- Trial name
- NCT00080236
- Testing
- IDN-6556
- Where
- 13 sites in United States, Germany
- Volunteers
- 99 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Liver Transplant
Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.
The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.
- Trial name
- MONTBLANC (NCT04471441)
- Testing
- Everolimus Tab., Mycophenolate mofetil Tab./Cap.
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Chong Kun Dang Pharmaceutical
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Transthyretin (TTR)-Mediated Amyloidosis, Familial Amyloidotic Polyneuropathy (FAP)
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant
The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation.
- Conditions
- Transthyretin (TTR)-Mediated Amyloidosis, Familial Amyloidotic Polyneuropathy (FAP), ATTR Amyloidosis, Familial Amyloid Neuropathies
- Trial name
- NCT02595983
- Testing
- Revusiran
- Where
- 6 sites in France, Germany and 4 more
- Volunteers
- 12 people
- Sponsor
- Alnylam Pharmaceuticals
Hepato Cellular Carcinoma (HCC), Liver Resection
Retrospective Clinical Validation of HepatoPredict
HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most…
- Conditions
- Hepato Cellular Carcinoma (HCC), Liver Resection, Liver Transplantation
- Trial name
- NCT06894524
- Volunteers
- 200 people
- Sponsor
- Ophiomics
Hepatitis B, Liver Transplantation
Evaluation of HepaGam B® in Combination With Antiviral Treatment in Hepatitis B Liver Transplant Patients
The purpose of the study is to assess the pharmacokinetics, safety and efficacy of HepaGam B in combination with antiviral therapy for the prevention of hepatitis B virus (HBV) recurrence following HBV-related orthotopic liver…
- Trial name
- NCT00722332
- Testing
- HepaGam B
- Where
- 16 sites in United States, Canada
- Volunteers
- 9 people
- Sponsor
- Cangene Corporation
Liver Transplantation
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants.
- Trial name
- NCT00717314
- Testing
- Mycophenolate mofetil, CNI (50%), CNI (≥75%)
- Where
- 11 sites in China
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
Liver Transplant
OCS Liver Perfusion (OLP) Post-Approval Registry
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device…
- Trial name
- NCT05074160
- Testing
- OCS Liver
- Where
- 9 sites in United States
- Volunteers
- 166 people
- Sponsor
- TransMedics
Liver Transplantation
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
- Trial name
- MARSILEA (NCT00295594)
- Testing
- tacrolimus
- Where
- 41 sites in Belgium, Denmark and 9 more
- Volunteers
- 627 people
- Sponsor
- Astellas Pharma Inc
Liver Transplant; Complications
POCS in Liver Transplantation Patients
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10…
- Trial name
- NCT03205072
- Testing
- Spy Glass DS
- Where
- 5 sites in United States, Brazil and 2 more
- Volunteers
- 42 people
- Sponsor
- Boston Scientific Corporation
Liver Transplantation
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as…
- Trial name
- NCT00378014
- Testing
- everolimus, basiliximab, CNI
- Where
- 16 sites in Austria, Germany and 2 more
- Volunteers
- 276 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation, Hepatitis C, Chronic
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at…
- Conditions
- Liver Transplantation, Hepatitis C, Chronic, Liver Cirrhosis
- Trial name
- NCT00378599
- Testing
- Combination of (a) pegylated interferon alfa-2b and (b) rebetol
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
Heart Transplantation, Kidney Transplantation
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- PROGRESSION (NCT01371344)
- Testing
- Tacrolimus granules, Tacrolimus capsules
- Where
- 12 sites in Belgium, France and 4 more
- Volunteers
- 47 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplant; Complications, Liver Transplant; Complications
Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox
Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients.
- Trial name
- NCT03848585
- Testing
- Pilloxa Pillbox, Non active Pilloxa Pillbox
- Where
- Sweden
- Volunteers
- 25 people
- Sponsor
- Pilloxa