Clinical trials: Liver Failure, Chronic
Hepatitis B
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤…
- Trial name
- NCT00426712
- Testing
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen, Hepatitis B Vaccine (Recombinant)
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Dynavax Technologies Corporation
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis C
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous…
- Trial name
- NCT01609933
- Testing
- ABT-450/r, ABT-267, pegylated interferon alpha-2a (pegIFN)
- Volunteers
- 32 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Chronic Liver Disease, Hepatic Encephalopathy
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- Trial name
- MHE (NCT01008293)
- Testing
- VSL#3, Lactulose
- Where
- India
- Volunteers
- 120 people
- Sponsor
- CD Pharma India Pvt. Ltd.
Hepatitis C, Hepatic Insufficiency
Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.
- Trial name
- NCT00314054
- Testing
- HCV-796
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4.
- Trial name
- NCT07347275
- Testing
- Standard of Care (Investigator Choice), DIALIVE 2.0 liver dialysis Device plus available Standard of Care
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- Yaqrit Ltd
Hepatitis C
Efficacy and Safety of Narlaprevir Used in Combination With Ritonavir in Treatment-Naïve and Failed Prior Treatment With Pegylated Interferon/Ribavirin Patients With Chronic Hepatitis C Genotype 1 (PIONEER - Study)
The purpose of this study was to confirm that combination of narlaprevir (NVR) and ritonavir (RTV) used as a metabolic inhibitor with pegylated interferon (PEG-INF) and ribavirin (RBV) leads to a superior Sustained Virological…
- Trial name
- PIONEER (NCT03833362)
- Testing
- Narlaprevir, Ritonavir, Pegylated interferon alfa-2a/ Pegylated interferon alfa-2b
- Where
- 20 sites in Russia
- Volunteers
- 420 people
- Sponsor
- R-Pharm
Hepatitis C
Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior…
- Trial name
- NCT02204475
- Testing
- Grazoprevir/Elbasvir, Boceprevir, PegIntron
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.
- Trial name
- NCT00781430
- Testing
- Neratinib (HKI-272)
- Where
- Russia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Puma Biotechnology, Inc.
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis.
- Trial name
- NCT00474955
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 5 sites in Russia
- Volunteers
- 27 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
Hepatitis b & Liver Dysfunction
Study on PK of Hydronidone in Patients and Special Population
1. Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction). 2.
- Trial name
- NCT04123769
- Testing
- Hydronidone
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, 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.
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.
Acute Liver Failure
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of…
- Trial name
- NCT01452295
- Testing
- ELAD (Extracorporeal Liver Assist System)
- Sponsor
- Vital Therapies, 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.