Clinical trials: Hepatic and Hepatobiliary Disorders
Advanced Chronic Liver Disease, Healthy Participants
A Study to Investigate the Pharmacokinetics of AZD2389 in Healthy Participants When Administered Alone and in Combination With Quinidine
The purpose of this study is to assess the pharmacokinetics (PK) and safety of AZD2389 when administered alone and in combination with quinidine in healthy participants.
- Trial name
- NCT06974565
- Testing
- AZD2389, Quinidine
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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)
Hepatic and Hepatobiliary Disorders
Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases
Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
- Trial name
- EPLID (NCT02517385)
- Testing
- Phosphatidylcholine
- Where
- Russia
- Volunteers
- 147 people
- Sponsor
- Sanofi
Alcoholic Liver Cirrhosis
Study to Evaluate Hepatic Artery Injection of Autologous Human Bone Marrow-Derived MSCs in Patients With Alcoholic LC
This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.
- Trial name
- NCT03838250
- Testing
- Cellgram™ (Bone marrow-derived MSCs)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Pharmicell Co., Ltd.
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
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and…
- Trial name
- NCT00856869
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Norgine
Liver Disease
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the…
- Trial name
- NCT01187186
- Testing
- ASP1941
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.
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
Moderate Hepatic Impairment, Severe Hepatic Impairment
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Liver Diseases
- Trial name
- NCT05116826
- Testing
- Nitazoxanide
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Genfit
Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease
Identification of Liver Fibrosis Biomarkers
Chronic liver disease (CLD) is a major cause of global mortality and morbidity . CLD patients are at an increased risk of developing liver fibrosis (formation of scar tissue), cirrhosis and liver failure and are at significant…
- Conditions
- Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- Trial name
- NCT06819917
- Testing
- Identification of liver fibrosis biomarkers
- Where
- 2 sites in Denmark, Germany
- Volunteers
- 575 people
- Sponsor
- Roche Diagnostics GmbH
Chronic Liver Disease
VIATORR Device Registry
The primary objective is to confirm the clinical performance and safety of the GORE® VIATORR® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis with Controlled Expansion throughout the device functional lifetime…
- Trial name
- NCT05661331
- Testing
- Transjugular intrahepatic portosystemic shunt
- Where
- 7 sites in Austria, France and 3 more
- Volunteers
- 196 people
- Sponsor
- W.L.Gore & Associates
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
Healthy Participants
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
- Trial name
- NCT06846528
- Testing
- AZD2389, Itraconazole
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase…
- Trial name
- NCT05395481
- Testing
- LY3849891
- Where
- 16 sites in United States, Japan and 1 more
- Volunteers
- 115 people
- Sponsor
- Eli Lilly and Company
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
Hepatic Insufficiency
Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency
This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.
- Trial name
- NCT00968591
- Testing
- Everolimus
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals