Clinical trials: Liver Transplant Disorder
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
Hepatitis B, Liver Transplantation
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection.
- Trial name
- NCT00228592
- Testing
- HepeX-B, Hepatitis B Immune Globulin (HBIg)
- Where
- 20 sites in United States, France and 5 more
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatitis B, Chronic
Nabi-HB Administered Subcutaneously in Patients With Hepatitis B Virus Post Liver Transplantation
A phase 3, multicenter, open label study to assess the safety and efficacy of Nabi-HB, administered subcutaneously in patients with Hepatitis B Virus Associated Liver Disease who underwent liver transplantation.
- Trial name
- Nabi-HB-SC (NCT00800787)
- Testing
- Nabi-HB
- Sponsor
- Biotest Pharmaceuticals Corporation
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT01938430
- Testing
- LDV/SOF, RBV
- Where
- 30 sites in United States
- Volunteers
- 339 people
- Sponsor
- Gilead Sciences
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
Liver Diseases, Liver Dysfunction
Global Utilization And Registry Database for Improved preservAtion of doNor Livers
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as…
- Conditions
- Liver Diseases, Liver Dysfunction, Liver Transplant Disorder, Liver Transplant Rejection
- Trial name
- NCT05082077
- Testing
- LIVERguard
- Where
- 15 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Paragonix Technologies
Hepatitis B Virus Associated Liver Disease
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation.
- Trial name
- NCT01421212
- Testing
- Hepatitis B Immune Globulin (Boca HBVIg)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Hepatitis C, Chronic, Healthy Volunteer
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection.
- Trial name
- NCT01371162
- Testing
- RO5428029
- Where
- 6 sites in France, Netherlands and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Urea Cycle Disorders, Carbamoylphosphate Synthetase I Deficiency
Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders
Urea cycle disorders are rare inherited diseases that generally have a poor outcome. In this study, neonates and infants with UCD will be included within the first 3 months of life and will be treated by repetitive application of…
- Conditions
- Urea Cycle Disorders, Carbamoylphosphate Synthetase I Deficiency, Ornithine Transcarbamylase Deficiency, Citrullinemia
- Trial name
- NCT00718627
- Testing
- Human Heterologous Liver Cells
- Where
- 2 sites in Germany
- Volunteers
- 12 people
- Sponsor
- Cytonet GmbH & Co. KG
Hepatitis B, Chronic (CHB)
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility.
- Trial name
- NCT00371761
- Testing
- Pegylated interferon alfa-2b (PegIntron), Adefovir dipivoxil (adefovir)
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver…
- Trial name
- NCT00298363
- Testing
- Tenofovir disoproxil fumarate (tenofovir DF; TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Entecavir (ETV)
- Where
- 38 sites in United States, Canada and 9 more
- Volunteers
- 112 people
- Sponsor
- Gilead Sciences
Hepatitis C
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.
- Trial name
- NCT01467505
- Testing
- Telaprevir, Ribavirin, Pegylated Interferon Alfa-2a
- Where
- 22 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.
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
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
Hepatitis C, Chronic
Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to patients who either failed to have at least a…
- Trial name
- NCT00062816
- Testing
- ISIS 14803, peginterferon alfa, ribavirin
- Where
- 25 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
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.
Chronic Hepatitis B
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
- Trial name
- NCT00140725
- Testing
- Lamivudine plus Polyethylene glyco-interferon alfa-2b, Lamivudine
- Where
- Hong Kong
- Volunteers
- 160 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, Human Immunodeficiency Virus
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
- Trial name
- NCT01667731
- Testing
- SOF, RBV
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 224 people
- Sponsor
- Gilead Sciences