Clinical trials: Hepatic Failure
Hepatic Encephalopathy
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
- Trial name
- NCT00597909
- Testing
- sodium phenylacetate and sodium benzoate injection 10% / 10%
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Amgen
Hepatic Insufficiency
A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function
This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic…
- Trial name
- NCT04226833
- Testing
- entrectinib
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Insufficiency
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
- Trial name
- NCT00859053
- Testing
- BMS-790052
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Cirrhosis, Hepatic Encephalopathy
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).
- Trial name
- HALT-HE (NCT00999167)
- Testing
- HPN-100
- Where
- 28 sites in United States
- Volunteers
- 189 people
- Sponsor
- Amgen
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
Acute Alcoholic Hepatitis
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day…
- Trial name
- NCT01471028
- Testing
- ELAD treatment, Standard of care (Control)
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 203 people
- Sponsor
- Vital Therapies, Inc.
Hepatic Insufficiency
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when…
- Trial name
- NCT02387814
- Testing
- Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia, Hepatic Insufficiency
Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)
This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy…
- Trial name
- NCT01043926
- Testing
- Suvorexant
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Encephalopathy
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
This study will look at the safety of a drug used in participants who have had hepatic encephalopathy (HE) in the past.
- Trial name
- NCT00686920
- Testing
- Rifaximin
- Where
- 35 sites in United States, Canada
- Volunteers
- 322 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy, Hepatic Insufficiency
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
- Trial name
- NCT02334800
- Testing
- Palbociclib 75 mg Capsule
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Acute Alcoholic Hepatitis
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.
- Trial name
- NCT02612428
- Testing
- ELAD System, Standard of Care (Control)
- Where
- 44 sites in United States, Austria and 4 more
- Volunteers
- 151 people
- Sponsor
- Vital Therapies, Inc.
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 Diseases, Hepatic Insufficiency
A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease
The main purpose of this study is to measure how much of the study drug called baricitinib gets into the blood stream and how long it takes the body to get rid of it. Healthy participants and those with liver disease may enroll.
- Trial name
- NCT01870388
- Testing
- Baricitinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Insufficiency, Hepatic Impairment
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06575959
- Testing
- Enlicitide
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to…
- Trial name
- NCT01512693
- Testing
- MK-0822
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Encephalopathy, Cirrhosis
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.
- Trial name
- NCT01842581
- Testing
- Rifaximin, Lactulose
- Where
- 43 sites in United States
- Volunteers
- 222 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company