Clinical trials: Transplantation, Liver
Pediatric Liver Transplantation
Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids
The study is planned to be conducted in 2 parts. The first part (open label, multi-center, non-controlled) of the study will estimate a dose that would provide a mycophenolic acid (MPA) exposure in pediatric participant that is…
- Trial name
- NCT02630563
- Testing
- Corticosteroids, Cyclosporine, mycophenolate mofetil
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Hoffmann-La Roche
Liver Transplantation, Transplantation Immunology
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
- Conditions
- Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction
- Trial name
- NCT00720408
- Testing
- Prograf-XL, Prograf, MMF
- Where
- 4 sites in Taiwan
- Volunteers
- 48 people
- Sponsor
- Astellas Pharma Inc
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.
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV)…
- Trial name
- NCT02251717
- Testing
- LDV/SOF
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 114 people
- Sponsor
- Gilead Sciences
Acute Liver Failure, Acute-On-Chronic Liver Failure
Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver).
- Trial name
- NCT03882346
- Testing
- LifeLiver
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- HLB Cell Co., Ltd.
Liver Transplantation
Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA)
To provide continued access for the LLT system to provide additional safety data in support of the PILOT pivotal efficacy and safety trial
- Trial name
- PILOT™_CA (NCT05574361)
- Testing
- Hypothermic Machine Perfusion
- Where
- 5 sites in United States
- Volunteers
- 385 people
- Sponsor
- Organ Recovery Systems, Inc.
Liver Transplantation
WP01 - Normothermic Liver Preservation
A multicenter randomized controlled trial to compare the efficacy of ex-vivo normothermic machine profusion with static cold storage in human liver transplantation.
- Trial name
- NCT02775162
- Testing
- Normothermic Machine Perfusion (NMP), Standard of Care (Ice)
- Where
- 15 sites in United States
- Volunteers
- 267 people
- Sponsor
- OrganOx Ltd.
Liver Transplant
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
- Trial name
- NCT05096754
- Testing
- OCS Liver
- Where
- 11 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Hemorrhage, Trauma
Quantra QStat in Trauma and Liver Transplant
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
- Conditions
- Hemorrhage, Trauma, Liver Transplant
- Trial name
- NCT04312958
- Testing
- Quantra System
- Where
- 10 sites in United States
- Volunteers
- 397 people
- Sponsor
- HemoSonics LLC
Hepatitis B
A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
- Trial name
- NCT05686759
- Testing
- Undiluted I.V.-Hepabig inj(GC5103), Diluted I.V.-Hepabig inj(GC5103)
- Where
- 8 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- GC Biopharma Corp
Liver Transplantation
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
- Trial name
- NCT00086346
- Testing
- Sirolimus (Rapamune), Cyclosporine or Tacrolimus
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 607 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also…
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Urea Cycle Disorders, Inborn
- Trial name
- NCT06805695
- Testing
- No Intervention
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 13 people
- Sponsor
- iECURE, Inc.
Blood Loss, Surgical
QStat in Liver Transplant
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
- Trial name
- NCT04114253
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
De Novo Kidney Transplant
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard…
- Trial name
- NCT00284921
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
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
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 Transplantation
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients.
- Trial name
- NCT00332462
- Testing
- Cyclosporine (Sandimmun® i.v.), Cyclosporine (Sandimmun® Optoral)
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.
- Trial name
- NCT01014390
- Testing
- WallFlex Biliary RX Fully Covered Stent System
- Where
- 13 sites in Australia, Austria and 9 more
- Volunteers
- 187 people
- Sponsor
- Boston Scientific Corporation