Clinical trials: End Stage Liver DIsease
Alcoholic Liver Cirrhosis
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
- Trial name
- NCT01591200
- Testing
- Allogeneic Mesenchymal Stem Cells
- Where
- 10 sites in India
- Volunteers
- 40 people
- Sponsor
- Stempeutics Research Pvt Ltd
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)
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd
Chronic Hepatitis C
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic…
- Trial name
- SOF/VEL ESRD (NCT03036852)
- Testing
- SOF/VEL
- Where
- 22 sites in Australia, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
- Trial name
- PK (NCT01708889)
- Testing
- BMS-914143 (Peginterferon Lambda-1a)
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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.
Hepatic Encephalopathy
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
- Trial name
- EMMPOWER (NCT04816916)
- Testing
- AXA1665
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Axcella Health, Inc
Acute-On-Chronic Liver Failure
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
The goal of this clinical trial is to learn if CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection (hereinafter referred to as CG-BM1) can treat acute-on-chronic liver failure (ACLF) patients.
- Trial name
- NCT06740149
- Testing
- Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1, Bone marrow mesenchymal stem cells (medium dose)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
Acute Liver Failure, Acute Liver Injury, Drug Induced
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure.
- Conditions
- Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
- Trial name
- NCT06285253
- Testing
- miroliverELAP treatment
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Miromatrix Medical Inc.
Acute on Chronic Hepatic Failure
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate.
- Trial name
- HEPATICUS-1 (NCT01079091)
- Testing
- ADVOS (Hepa Wash), Standard Medical Therapy
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- Hepa Wash GmbH
Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF)
A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard…
- Conditions
- Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis
- Trial name
- NCT06987968
- Testing
- VS-01 on top of SOC (Active Treatment Group), SOC
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Genfit
Chronic Hepatitis C Virus
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)
The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in…
- Trial name
- GIFT-R (NCT02806362)
- Testing
- Ombitasvir/paritaprevir/ritonavir
- Sponsor
- AbbVie
Hepatitis B
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease
The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients.
- Trial name
- NCT00498212
- Testing
- 1018 ISS-HBsAg-Single, 1018 ISS-HBsAg-Double
- Where
- 3 sites in Canada
- Volunteers
- 41 people
- Sponsor
- Dynavax Technologies Corporation
Hepatitis C, Chronic
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and…
- Trial name
- NCT02864199
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 17 sites in United States, Brazil and 3 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
Hepatic Encephalopathy, Liver Failure
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2…
- Conditions
- Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis
- Trial name
- NCT00287235
- Testing
- MARS, Standard Medical Therapy
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 70 people
- Sponsor
- Vantive Health LLC
Chronic Kidney Disease
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
The purpose of this study is to determine the durability of seroprotection of HEPLISAV™ and Engerix-B® and the number of injections of each vaccine needed to maintain seroprotection in a cohort of chronic kidney disease (CKD)…
- Trial name
- NCT01282762
- Testing
- HEPLISAV, Engerix-B
- Where
- United States
- Volunteers
- 147 people
- Sponsor
- Dynavax Technologies Corporation
End Stage Liver Disease
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
- Trial name
- NCT04496479
- Testing
- LYG-LIV0001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- LyGenesis, Inc.
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
Acute-On-Chronic Liver Failure
Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.
- Trial name
- APACHE (NCT03702920)
- Testing
- SMT + PE-A 5%, Standard Medical Treatment
- Where
- 30 sites in United States, Austria and 7 more
- Volunteers
- 274 people
- Sponsor
- Instituto Grifols, S.A.