Clinical trials: Hepatobiliary Disease
Liver Disease
A Phase II Study of DMP 115 to Assess Focal Liver Lesions
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.
- Trial name
- NCT00162058
- Testing
- Peflutren Lipid Microsphere Injectable Suspension
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- Lantheus Medical Imaging
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
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT01938430
- Testing
- LDV/SOF, RBV
- Where
- 30 sites in United States
- Volunteers
- 339 people
- 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.
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
Hepatocellular Carcinoma
A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-pugh B7 and B8 Cirrhosis
The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC)…
- Trial name
- Kirros (NCT06096779)
- Testing
- Atezolizumab, Bevacizumab
- Where
- 54 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Genentech, Inc.
Fatty Liver
The Effect of a Probiotic on Hepatic Steatosis
Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States.
- Trial name
- NCT00099723
- Testing
- VSL#3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- VSL Pharmaceuticals
Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH).
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease
- Trial name
- NCT05877547
- Testing
- Efinopegdutide, Semaglutide
- Where
- 175 sites in United States, Austria and 24 more
- Volunteers
- 381 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
Non Alcoholic Fatty Liver
Efficacy and Safety of a Probiotic Composition as Adjunct in MAFL Management
Some studies have shown beneficial results with probiotics on hepatic function of subjects with fatty liver, but significant variability has been noted among probiotic formulations.
- Trial name
- NCT04823676
- Testing
- Probiotic composition
- Where
- Mexico
- Volunteers
- 100 people
- Sponsor
- AB Biotics, SA
Non-Alcoholic Fatty Liver Disease (NAFLD)
Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose of 1000 mg once daily; Proliverenol at a…
- Trial name
- NCT06127225
- Testing
- Proliverenol
- Where
- Indonesia
- Volunteers
- 80 people
- Sponsor
- Dexa Medica Group
Liver Diseases, Liver Fibrosis
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.
- Conditions
- Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis
- Trial name
- NCT03479125
- Testing
- Ultrasound
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-alcoholic Steatohepatitis
Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.
- Trial name
- NCT06297434
- Testing
- J2H-1702
- Where
- 11 sites in South Korea
- Volunteers
- 87 people
- Sponsor
- J2H Biotech
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease in Women With PCOS
Saroglitazar Magnesium 4 mg in the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Women With PCOS (EVIDENCES VII)
This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
- Trial name
- NCT03617263
- Testing
- Saroglitazar Magnesium 4 mg Tablet
- Where
- 19 sites in United States, Mexico
- Volunteers
- 60 people
- Sponsor
- Zydus Therapeutics Inc.
NON-ALCOHOLIC STEATOHEPATITIS
Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT06054815
- Testing
- DA-1241, Sitagliptin
- Where
- 18 sites in United States
- Volunteers
- 109 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Nonalcoholic Steatohepatitis
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis
This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group.
- Trial name
- NCT01466894
- Testing
- IMM 124-E
- Sponsor
- Immuron Ltd.
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease.
- Trial name
- NCT03938246
- Testing
- TVB-2640 25 mg (US), TVB-2640 50 mg (US), TVB-2640 50 mg (China)
- Where
- 23 sites in United States, China
- Volunteers
- 142 people
- Sponsor
- Sagimet Biosciences Inc.
Hepatocellular Carcinoma (HCC)
Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
- Trial name
- NCT02794805
- Testing
- ¹³C-Octanoate Breath Test
- Where
- 2 sites in China
- Volunteers
- 74 people
- Sponsor
- Meridian Bioscience, Inc.
Healthy, NAFLD
DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.
The primary objective of this study is to evaluate the effect of itraconazole, a strong inhibitor)of cytochrome P4503A , and phenytoin a strong inducer of cytochrome P450 3A, CYP3A4, CYP1A2 and CYP2C19 on the pharmacokinetics of…
- Trial name
- NCT04845646
- Testing
- ASC41, Itraconazole, Phenytoin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gannex Pharma Co., Ltd.