Clinical trials: Hepatobiliary Disorders
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Decompensated Cirrhosis
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new…
- Trial name
- ENCORE-LF (NCT03205345)
- Testing
- Emricasan (25 mg), Emricasan (5 mg)
- Where
- 76 sites in United States
- Volunteers
- 210 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Non-Alcoholic Fatty Liver
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an…
- Trial name
- NCT03953456
- Testing
- elafibranor 120mg
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Genfit
Nonalcoholic Steatohepatitis
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M…
- Trial name
- FORTUNA (NCT05809934)
- Testing
- AZD2693
- Where
- 163 sites in United States, Argentina and 20 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Nonalcoholic Steatohepatitis (NASH)
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02854605
- Testing
- GS-9674
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 140 people
- Sponsor
- Gilead Sciences
Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH)
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor, fluvoxamine, in healthy participants.
- Trial name
- NCT05712265
- Testing
- Miricorilant, Fluvoxamine
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Corcept Therapeutics
MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
- Trial name
- NCT07581951
- Testing
- HSK31679
- Where
- China
- Volunteers
- 886 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic…
- Trial name
- NCT07589400
- Testing
- ACT500 Tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
Non-alcoholic Steatohepatitis (NASH)
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in participants with…
- Trial name
- NCT04483947
- Testing
- AZD2693
- Where
- 16 sites in United States
- Volunteers
- 74 people
- Sponsor
- AstraZeneca
Liver Disease
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery.
- Trial name
- NCT01324349
- Testing
- Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Healthy, NAFLD
Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers
This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.
- Conditions
- Healthy, NAFLD, Hyperlipidemia
- Trial name
- NCT04692025
- Testing
- ASC41 tablet
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gannex Pharma Co., Ltd.
Non Alcoholic Fatty Liver
Evaluation of MF4637 for Correcting the Omega-3 Nutritional Deficiency in NAFLD Patients
This study is a prospective, randomized, placebo-controlled, double-blind trial to determine the effect of high concentrate omega-3 capsules on the omega-3 status of patients with non-alcoholic fatty liver.
- Trial name
- NCT02923804
- Testing
- Omega-3, Olive oil
- Where
- 7 sites in United States
- Volunteers
- 172 people
- Sponsor
- Pronova BioPharma
Non-alcoholic Steatohepatitis (NASH)
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
- Trial name
- NCT02316717
- Testing
- IMM-124E
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 133 people
- Sponsor
- Immuron Ltd.
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
NASH - Nonalcoholic Steatohepatitis
Study to Evaluate MET642 in Patients With NASH
A randomized, double-blind, placebo-controlled study to evaluate MET642 in NASH patients.
- Trial name
- NCT04773964
- Testing
- MET642
- Where
- United States
- Volunteers
- 215 people
- Sponsor
- Metacrine, Inc.
Hepatocellular Carcinoma and Liver Disease
HELIO Liver Test Performance Study in China (HEPATIC)
De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
- Trial name
- HEPATIC (NCT05053412)
- Testing
- Helio Liver Test
- Where
- 2 sites in China
- Volunteers
- 1,556 people
- Sponsor
- Helio Genomics
NASH - Nonalcoholic Steatohepatitis
Phase 2a Study of HPG1860 in Subjects With NASH
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
- Trial name
- RISE (NCT05338034)
- Testing
- HPG1860
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Hepagene (Shanghai) Co., Ltd.