Clinical trials: End Stage Liver DIsease
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, 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
Acute-on-Chronic Liver Failure
Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers
A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
- Trial name
- NCT07110441
- Testing
- Single Dose G1090N, Multiple dosing of G1090N
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Genfit
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.
Liver Cirrhosis, Liver Failure
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".
- Trial name
- NCT01201720
- Testing
- Plasma exchange with albumin
- Where
- Spain
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Instituto Grifols, S.A.
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
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.
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 Hepatic Failure, Acute Liver Failure
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver…
- Conditions
- Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis
- Trial name
- NCT01937130
- Testing
- IDN-6556
- Where
- 26 sites in United States, United Kingdom
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Liver Failure, Acute on Chronic
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
- Trial name
- NCT03863002
- Testing
- Mesenchymal Stem Cell
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Tianjin Weikai Bioeng., Ltd.
Acute-On-Chronic Liver Failure
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
- Trial name
- HEP101 (NCT02946554)
- Testing
- HepaStem
- Where
- 10 sites in Belgium, France
- Volunteers
- 24 people
- Sponsor
- Cellaion SA
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
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 (ACLF), Hepatic Encephalopathy (HE)
RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants…
- Trial name
- NCT07429838
- Testing
- metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx), EGEN-5784 (genetically engineered porcine liver)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- eGenesis, INC
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
Kidney Failure, Liver Failure, Chronic
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol…
- Conditions
- Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure
- Trial name
- NCT03627013
- Testing
- Custodiol-N Solution, Custodiol HTK Solution
- Where
- 4 sites in Austria
- Volunteers
- 362 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
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
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
Hepatocellular Carcinoma
Trial of TRC105 and Sorafenib in Patients With HCC
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma.
- Trial name
- NCT02560779
- Testing
- Carotuximab (TRC105), Sorafenib
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Tracon Pharmaceuticals Inc.
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.