Clinical trials: Hepatobiliary Disease
Liver Disease
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.
The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.
- Trial name
- NCT04408937
- Testing
- triopifexor
- Where
- 10 sites in United States
- Volunteers
- 89 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants
A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.
- Trial name
- NCT06138795
- Testing
- AZD2389
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Non-alcoholic Steatohepatitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Trial name
- BANFF (NCT04171765)
- Testing
- BFKB8488A
- Where
- 53 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- Genentech, 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
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.
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.
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese
Nonalcoholic fatty liver disease (NAFLD) is a progressive liver disease ranging from simple steatosis to cirrhosis of the liver.
- Trial name
- NCT03282305
- Volunteers
- 5,000 people
- Sponsor
- Great China Fatty Liver Consortium Limited
NASH - Nonalcoholic Steatohepatitis
A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of SNP-610 for the Treatment of Patients With Non-alcoholic Steatohepatitis
The primary objective of the study is to compare the changes in serum ALT level among patients with non-alcoholic steatohepatitis (NASH) following 3-month treatment of 800 mg SNP-610 or the placebo.
- Trial name
- NCT03468556
- Testing
- SNP-610
- Volunteers
- 80 people
- Sponsor
- Sinew Pharma Inc.
Cholestasis, Intrahepatic
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease.
- Trial name
- NCT06183242
- Testing
- Remaxa, enteric-coated tablets, Remaxol
- Where
- 3 sites in Russia
- Volunteers
- 328 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
NASH - Nonalcoholic Steatohepatitis
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination…
- Trial name
- NCT03294941
- Testing
- HepQuant SHUNT Liver Diagnostic Kit
- Where
- 8 sites in United States
- Volunteers
- 17 people
- Sponsor
- HepQuant, LLC
NASH - Nonalcoholic Steatohepatitis
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks.
- Trial name
- NCT04697810
- Testing
- Namodenoson
- Where
- 24 sites in Bosnia and Herzegovina, Bulgaria and 4 more
- Volunteers
- 114 people
- Sponsor
- Can-Fite BioPharma
Nonalcoholic Steatohepatitis
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on…
- Trial name
- CONTROL (NCT02633956)
- Testing
- Obeticholic Acid, Atorvastatin
- Where
- 22 sites in United States
- Volunteers
- 84 people
- Sponsor
- Intercept Pharmaceuticals
Liver Diseases
Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.
- Trial name
- NCT00861601
- Testing
- eltrombopag 12.5 milligrams (mg) tablet, eltrombopag 25 mg tablet
- Where
- 10 sites in Japan
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Hepatocellular Carcinoma (HCC)
A Phase 1 Study of Fisogatinib (BLU-554) in Patients With Hepatocellular Carcinoma
This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of fisogatinib (formerly known as BLU…
- Trial name
- NCT02508467
- Testing
- Fisogatinib (BLU-554)
- Where
- 41 sites in United States, China and 10 more
- Volunteers
- 146 people
- Sponsor
- Blueprint Medicines Corporation
Nonalcoholic Steatohepatitis
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of…
- Trial name
- NASH-FX (NCT02421094)
- Testing
- GR-MD-02
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Galectin Therapeutics Inc.
Non-alcoholic Steatohepatitis
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in participants with biopsy-proven Non-alcoholic Steatohepatitis (NASH).
- Trial name
- NCT02912260
- Testing
- MGL-3196
- Where
- 26 sites in United States
- Volunteers
- 125 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Intestinal Failure Associated Liver Disease
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated…
- Trial name
- NCT05919680
- Testing
- NST-6179 Part A, NST-6179 Part B
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- NorthSea Therapeutics B.V.
NASH - Nonalcoholic Steatohepatitis
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human…
- Trial name
- NCT03610945
- Testing
- Fluconazole, Quinidine, EDP-305
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc