Clinical trials: Liver Transplants
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 Transplantation, Mycoses
Liver Transplant European Study Into the Prevention of Fungal Infection
Prevention of invasive fungal infection in high risk patients following liver transplant.
- Trial name
- TENPIN (NCT01058174)
- Testing
- micafungin, fluconazole, liposomal amphotericin B
- Where
- 36 sites in Austria, Belgium and 12 more
- Volunteers
- 350 people
- Sponsor
- Astellas Pharma Inc
Hemophilia, Hemophilia B
Study Evaluating Liver Transplantation in Haemophilia Patients in Spain
This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain
- Trial name
- NCT00927992
- Testing
- Epidemiological Non interventional
- Volunteers
- 11 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatitis B, Chronic
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
- Trial name
- NCT00395018
- Testing
- entecavir
- Where
- 32 sites in United States, Argentina and 7 more
- Volunteers
- 109 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Liver Transplantation
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
- Trial name
- CHASE (NCT00295607)
- Testing
- Tacrolimus, steroids, monoclonal anti-IL2R antibody
- Where
- 17 sites in Czechia, France and 6 more
- Volunteers
- 138 people
- Sponsor
- Astellas Pharma Inc
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
Liver Transplant
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored…
- Trial name
- NCT00149994
- Testing
- Cyclosporine A, Tacrolimus, Basiliximab
- Where
- Switzerland
- Volunteers
- 171 people
- Sponsor
- Novartis Pharmaceuticals
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
Liver Dysfunction, Rejection, Transplant
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection.
- Conditions
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- Trial name
- NCT00117689
- Testing
- Thymoglobulin, Corticosteroid, Tacrolimus
- Where
- 16 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
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
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype…
- Trial name
- CORAL-I (NCT01782495)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 129 people
- Sponsor
- AbbVie
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C Virus (HCV) Infection
An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.
- Trial name
- REPLACE (NCT01571583)
- Testing
- Telaprevir, Pegylated interferon alfa-2a, Ribavirin
- Where
- 21 sites in Austria, Belgium and 4 more
- Volunteers
- 74 people
- Sponsor
- Janssen-Cilag International NV
Hepatitis B
Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion…
- Trial name
- NCT01590615
- Testing
- Anti-HBV nucleoside/nucleotide therapy
- Where
- 27 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Gilead Sciences
Hepatitis B Infection
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients
This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
- Trial name
- NCT02304315
- Testing
- GC1102 50,000 IU, GC1102 80,000 IU
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Green Cross Corporation
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 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
Liver Transplant Surgery, Liver Transplantation
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.
- Trial name
- NCT06916325
- Testing
- dual hypothermic oxygenated perfusion (DHOPE)
- Volunteers
- 215 people
- Sponsor
- XVIVO Perfusion
Liver Transplant
US National OCS Liver Perfusion (OLP) Registry
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
- Trial name
- National OLP (NCT05940857)
- Testing
- OCS Liver
- Where
- 22 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals