Clinical trials: Hepatic and Hepatobiliary Disorders
Hepatic Impairment, Healthy Participants
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
- Trial name
- NCT04193436
- Testing
- PF-06835919 25 mg
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Liver Disease
Study to Assess the Safety, Tolerability, and Pharmacodynamics of RTA 402 in Patients With Hepatic Dysfunction
This study assesses the safety and tolerability of RTA 402 in patients with liver disease.
- Trial name
- NCT00550849
- Testing
- RTA 402
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Biogen
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
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.
Nonalcoholic Steatohepatitis (NASH)
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK…
- Trial name
- HI (NCT02891408)
- Testing
- Firsocostat, Fenofibrate
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
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.
Schizophrenia, Schizoaffective Disorder
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
- Trial name
- NCT00535145
- Testing
- Treatment as usual (TAU), Paliperidone ER
- Where
- 21 sites in United States
- Volunteers
- 121 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
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
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
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
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.
End Stage Liver Disease
Allogenic Hepatocyte Transplantation Into Periduodenal Lymph Nodes
This Phase 2a clinical trial is a dose escalation study of the safety, tolerability, and efficacy of hepatocyte transplantation into lymph nodes via endoscopic ultrasound among subjects with end-stage liver disease.
- Trial name
- NCT04496479
- Testing
- LYG-LIV0001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- LyGenesis, Inc.
Hepatic Cirrhosis, Liver Fibrosis
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage…
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 2 (NCT03486912)
- Testing
- BMS-986036
- Where
- 91 sites in United States, Japan
- Volunteers
- 155 people
- Sponsor
- Bristol-Myers Squibb
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- DPAILO-1 (NCT06344364)
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- 3 sites in Hong Kong, Spain
- Volunteers
- 1,241 people
- Sponsor
- PharmaNest, 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.
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences
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
Liver Disease, Hyponatremia
Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function
- Trial name
- NCT00851227
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
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.
Non-alcoholic Fatty Liver Disease (NAFLD)
Study of Magnetic Resonance Imaging (MRI) to Quantify Liver Fat in Diabetic and Pre-Diabetic Patients (0000-171)
This study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two MRI-based methods.
- Trial name
- NCT01110577
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC