Clinical trials: Liver Transplant
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
Liver Transplant
OCS Liver DCD Trial
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
- Trial name
- NCT04194437
- Testing
- OCS Liver System
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- TransMedics
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 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
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 Transplantation
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
- Trial name
- HEPHAISTOS (NCT01551212)
- Testing
- Everolimus, Tacrolimus, Corticosteroids
- Where
- 15 sites in Germany
- Volunteers
- 339 people
- Sponsor
- Novartis Pharmaceuticals
Sequelae of Viral Hepatitis, Transplantation Infection
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.
- Conditions
- Sequelae of Viral Hepatitis, Transplantation Infection, Evidence of Liver Transplantation
- Trial name
- NCT00473824
- Testing
- Hepatitis C Immune Globulin Intravenous (Human) 5%
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- ADMA Biologics, Inc.
Liver Failure
Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00608244
- Testing
- LCP Tacro, Prograf
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Veloxis Pharmaceuticals
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with…
- Trial name
- POLARIS-3 (NCT02639338)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 70 sites in United States, Australia and 6 more
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Liver Transplantation
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
- Trial name
- NCT01888432
- Testing
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Where
- 42 sites in United States, Canada and 11 more
- Volunteers
- 285 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing…
- Trial name
- NCT02728206
- Testing
- SOF/VEL
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Gilead Sciences
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
Hepatitis C, Chronic
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of…
- Trial name
- NCT00087633
- Testing
- peginterferon alfa-2a [Pegasys], Copegus
- Where
- 28 sites in United States
- Volunteers
- 115 people
- Sponsor
- Hoffmann-La Roche
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
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 Failure
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by…
- Trial name
- NCT00772148
- Testing
- LCP -Tacro, Prograf
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Veloxis Pharmaceuticals
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
Immunosuppression in Solid Organ Transplant
Belatacept in Liver Transplant Recipients
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
- Trial name
- NCT00555321
- Testing
- Tacrolimus, Basiliximab, Belatacept More Intensive (MI)
- Where
- 42 sites in United States, Argentina and 7 more
- Volunteers
- 260 people
- Sponsor
- Bristol-Myers Squibb