Clinical trials: Hepatic
Septic Shock, Acute Respiratory Distress Syndrome
CytOSorb TreatMent Of Critically Ill PatientS Registry
Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based…
- Conditions
- Septic Shock, Acute Respiratory Distress Syndrome, Trauma, Rhabdomyolysis
- Trial name
- COSMOS (NCT05146336)
- Testing
- CytoSorb
- Where
- 28 sites in Austria, Germany and 4 more
- Volunteers
- 3,000 people
- Sponsor
- CytoSorbents, Inc
Overactive Bladder
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index…
- Trial name
- NCT01737684
- Testing
- Vibegron
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational…
- Trial name
- NCT01916993
- Testing
- NBI-98854 50 mg capsule
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment…
- Trial name
- NCT03555565
- Testing
- Alogliptin and Metformin hydrochloride
- Where
- Japan
- Volunteers
- 1,026 people
- Sponsor
- Takeda
Hepatic Encephalopathy
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
- Trial name
- NCT01846663
- Testing
- Rifaximin
- Where
- 28 sites in United States
- Volunteers
- 6 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy, Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod
This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).
- Trial name
- NCT04819464
- Testing
- Cenerimod
- Where
- 2 sites in Hungary, Portugal
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viatris Innovation GmbH
Healthy Volunteers, Hepatic Insufficiency
A Single Dose Study of LY2605541 in Participants With Liver Impairment
The primary purpose of this study is to help answer the following research questions: To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those…
- Conditions
- Healthy Volunteers, Hepatic Insufficiency, Diabetes Mellitus, Type 2
- Trial name
- NCT01751399
- Testing
- LY2605541
- Where
- 2 sites in Germany, Hungary
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Portal Hypertension Related to Cirrhosis, Ascites Hepatic
Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal…
- Conditions
- Portal Hypertension Related to Cirrhosis, Ascites Hepatic, Variceal Bleeding
- Trial name
- NCT06669806
- Testing
- TIPS Stent Graft
- Where
- China
- Volunteers
- 166 people
- Sponsor
- C. R. Bard
Gaucher Disease
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Primary Objective: To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat. Secondary Objective: To assess the tolerability of eliglustat tartrate given as a single dose in subjects…
- Trial name
- NCT02536911
- Testing
- eliglustat
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Healthy Volunteer
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with…
- Trial name
- NCT01714154
- Testing
- danoprevir, ritonavir, setrobuvir
- Where
- 3 sites in Hungary, Poland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyria (XLP)
Expanded Access Program of Bitopertin For Participants With EPP or XLP
The goal of this expanded access program is to provide bitopertin to patients with EPP and XLP who have no satisfactory treatment options available in the US and to learn if bitopertin is safe to treat EPP and XLP.
- Trial name
- NCT07603401
- Testing
- DISC-1459
- Where
- 7 sites in United States
- Sponsor
- Disc Medicine, Inc
Hepatic Impairment, Healthy
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.
- Trial name
- NCT07269301
- Testing
- PF-07328948
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Cirrhosis, Portal Hypertension
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin.
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT03827200
- Testing
- Ambrisentan
- Where
- 6 sites in Spain
- Volunteers
- 19 people
- Sponsor
- Noorik Biopharmaceuticals AG
Anaemia
Daprodustat Hepatic Impairment Study
Daprodustat (GSK1278863), is a small molecule currently in development for the treatment of anemia of chronic kidney disease (CKD).
- Trial name
- NCT03223337
- Testing
- Daprodustat (GSK1278863)
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched…
- Trial name
- NCT07783308
- Testing
- AZD4144
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Insufficiency, Renal Insufficiency
Study of Copanlisib in Hepatic or Renal Impairment
To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects
- Trial name
- NCT03172884
- Testing
- Copanlisib (ALIQOPA, BAY80-6946)
- Where
- 2 sites in Germany, Romania
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer