Clinical trials: Hepatic and Hepatobiliary Disorders
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Impairment
Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.
- Trial name
- NCT05751759
- Testing
- Mitiperstat
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Hepatic Impairment, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
Moderate Liver Impairment, Severe Liver Impairment
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment.
- Trial name
- NCT04634149
- Testing
- BMS-986036
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Liver Cirrhosis
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients
The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein…
- Trial name
- NCT04987034
- Testing
- EchoTip® Insight™
- Where
- 3 sites in Belgium, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Cook Research Incorporated
Liver Fibrosis, Hepatic Cirrhosis
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
- Trial name
- BRAVO (NCT07610837)
- Testing
- AZD2389
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 104 people
- Sponsor
- AstraZeneca
Healthy
Investigating the Effects of a High GI Versus a Low GI Diet on Hepatic Metabolism and Satiety Levels in Healthy Subjects
The aim of this study is to investigate the effect of a one week high versus low glycaemic index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a two way cross overs study and to see if…
- Trial name
- NCT02482558
- Testing
- High/Low Glycaemic index test breakfast
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo.
- Trial name
- MAESTRO-NAFLD1 (NCT04197479)
- Testing
- Resmetirom
- Where
- 77 sites in United States, Puerto Rico
- Volunteers
- 1,343 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Hepatic Impairment
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
- Trial name
- NCT04469920
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 2 sites in United States
- Volunteers
- 98 people
- Sponsor
- Zydus Therapeutics Inc.
Chronic Liver Disease, Cirrhosis
MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy
The purpose of this study is to determine the effect on the (carbon 13 labelled(13C)-Methacetin Breath Test (MBT) of i.v. propranolol, a non-selective beta blocker (NSBB) following initial administration and after chronic use of…
- Conditions
- Chronic Liver Disease, Cirrhosis, Esophageal Varices, Portal Hypertension
- Trial name
- NCT01851252
- Testing
- Methacetin (with Breath testing device)
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatic Encephalopathy
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
The purpose of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
- Trial name
- AST015 (NCT00558038)
- Testing
- AST-120, lactulose
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Ocera Therapeutics
Cardiac Disorder, Hepatic Disorder
Kosmos Anatomical Object Labeling and View Identification Pivotal Study
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers.
- Conditions
- Cardiac Disorder, Hepatic Disorder, Spleen Disorder, Kidney Disorder
- Trial name
- NCT06468787
- Testing
- Kosmos Anatomical Object Labeling and View Identification Algorithms
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.