Clinical trials: Transplant, Liver
Liver Transplantation
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
- Trial name
- NCT00909571
- Testing
- FK506E (modified release tacrolimus), Prograf (tacrolimus)
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation
OrganOx Metra® New Enrollment PAS
The objective of the OrganOx metra® New Enrollment Post-Approval Study is to collect data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on the OrganOx according to the current…
- Trial name
- NCT05526326
- Testing
- Transplant with normothermic machine perfused (NMP) donor liver
- Where
- 10 sites in United States
- Volunteers
- 315 people
- Sponsor
- OrganOx Ltd.
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 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
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
Rejection; Transplant, Liver, Liver Failure
Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal.
- Conditions
- Rejection; Transplant, Liver, Liver Failure, Liver Diseases
- Trial name
- LIBERATE (NCT05234190)
- Testing
- QEL-001
- Where
- 10 sites in Belgium, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- Quell Therapeutics Limited
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
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.
- Trial name
- NCT01381432
- Testing
- Azathioprine
- Volunteers
- 39 people
- Sponsor
- GlaxoSmithKline
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.
HCV Infection
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of multiple doses of ACH-0137171 in participants with chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT00401947
- Testing
- ACH-0137171
- Where
- 9 sites in United States, Germany and 1 more
- Volunteers
- 30 people
- Sponsor
- Alexion 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 Transplant Rejection
TRU-IMMUNO: Optimizing Liver Immunosuppression
This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide…
- Trial name
- NCT05335551
- Testing
- Patients monitored with TruGraf and TRAC Liver testing
- Volunteers
- 130 people
- Sponsor
- Transplant Genomics, Inc.
Recurrent Hepatocellular Carcinoma
A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation
Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries.
- Trial name
- NCT03634683
- Testing
- LioCyx
- Where
- 3 sites in China, Singapore
- Sponsor
- Lion TCR Pte. Ltd.
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.
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 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