Clinical trials: Orthotopic Liver Transplantation
Ischemia-reperfusion Injury in Liver Transplant, Early Allograft Dysfunction
Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
The objective of the study is to evaluate the efficacy and safety of Reparixin treatment (2.772 mg/kg body weight/hour intravenous continuous infusion for 7 days) based on incidence of early allograft dysfunction within the first…
- Trial name
- NCT03031470
- Testing
- Reparixin, Control
- Where
- 7 sites in Belarus, Russia
- Volunteers
- 40 people
- Sponsor
- Dompé Farmaceutici S.p.A
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
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
Hepatitits C
An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant
The purpose of this study is to evaluate sustained virologic response 12 weeks after the end of treatment (SVR12) following 12 weeks of simeprevir plus sofosbuvir with and without ribavirin (RBV) and 24 weeks of simeprevir plus…
- Trial name
- GALAXY (NCT02165189)
- Testing
- Simeprevir, Sofosbuvir, Ribavirin
- Where
- 11 sites in United States
- Volunteers
- 46 people
- Sponsor
- Janssen Scientific Affairs, LLC
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
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
Hepatitis C Infection, Viruses
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
- Conditions
- Hepatitis C Infection, Viruses, Hepatocellular Carcinoma, Hepatitis, Viral, Human
- Trial name
- NCT01804829
- Testing
- Civacir® 10%
- Where
- 23 sites in United States
- Volunteers
- 80 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Coagulopathy, Endstage Liver Disease
Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT).
- Trial name
- NCT02037373
- Testing
- Octaplas™, Plasma
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Octapharma
Liver Diseases
YSPSL for Prevention of Delayed Graft Function in Cadaveric 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
- NCT00450398
- Testing
- YSPSL
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Y's Therapeutics, Inc.
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
HCV Recurrence After Liver Transplantation
Legalon SIL for the Treatment of HCV Recurrence in Liver Transplanted Patients
Orthotopic liver transplantation (OLT) is the treatment of choice for patients with Hepatitis C Virus (HCV) infection and end-stage liver disease or hepatocellular carcinoma; infection of the graft and hepatitis C recurrence is…
- Trial name
- NCT01535092
- Testing
- Silibinin
- Volunteers
- 14 people
- Sponsor
- Rottapharm
Acquired Bleeding Disorder, Bleeding During/Following Surgery
Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
- Trial name
- NCT01563458
- Testing
- activated recombinant human factor VII
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 208 people
- Sponsor
- Novo Nordisk A/S
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
Cytomegalovirus Infections
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a…
- Trial name
- NCT00497796
- Testing
- maribavir, ganciclovir
- Where
- 55 sites in United States
- Volunteers
- 307 people
- Sponsor
- Shire
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
Amyloidosis, Familial, Transthyretin Amyloidosis
Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver…
- Trial name
- NCT03862807
- Testing
- Patisiran
- Where
- 9 sites in France, Germany and 5 more
- Volunteers
- 24 people
- Sponsor
- Alnylam Pharmaceuticals
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 Transplantation
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
- Trial name
- PILOT™ (NCT03484455)
- Testing
- Hypothermic machine perfusion, Static cold storage
- Where
- 9 sites in United States
- Volunteers
- 142 people
- Sponsor
- Organ Recovery Systems, 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.
Hepatitis B, Liver Transplantation
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver…
- Trial name
- NCT01131065
- Testing
- Hepatitis B immune globulin
- Where
- 4 sites in Italy
- Volunteers
- 15 people
- Sponsor
- Instituto Grifols, S.A.