Clinical trials: Hepatobiliary Disorders
Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots…
- Conditions
- Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia
- Trial name
- NCT01327872
- Testing
- E5501 40 mg 2 x 20-mg tablets, orally, fasted, E5501 40 mg 2 x 20-mg tablets, orally, with food, E5501 40mg 2 x 20-mg tablets, orally, fasted
- Where
- Netherlands
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Pancreas Cancer, Hepatobiliary Cancer
NCI SBIR Contract for Patient Navigation Tool Prototype Development
GMG ArcData will create a mobile-based application to improve communications and data exchange among patients and navigators involved in new pancreas surgery oncology episodes of care.
- Conditions
- Pancreas Cancer, Hepatobiliary Cancer, Patient Engagement
- Trial name
- NCT04892927
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- GMG Arcdata LLC
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Liver Fibrosis, Hepatic Cirrhosis
Study of AZD2389 Safety, Tolerability, and Pharmacodynamics in Adults With Steatotic Liver Disease and Advanced Fibrosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacodynamic effects of AZD2389 in adult participants with steatotic liver disease (SLD) and advanced fibrosis.
- Trial name
- BRAVO (NCT07610837)
- Testing
- AZD2389
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 104 people
- Sponsor
- AstraZeneca
Non-alcoholic Fatty Liver Disease, Obesity
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease…
- Trial name
- NCT05970640
- Testing
- BI 3006337
- Where
- 12 sites in United States
- Volunteers
- 64 people
- Sponsor
- Boehringer Ingelheim
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.
Hyperoxaluria, Nonalcoholic Fatty Liver Disease
A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
The purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo.
- Conditions
- Hyperoxaluria, Nonalcoholic Fatty Liver Disease, Kidney Stone
- Trial name
- NCT06138327
- Testing
- BMN 255
- Where
- 7 sites in United States
- Sponsor
- BioMarin Pharmaceutical
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
- Trial name
- NCT04829123
- Testing
- HEC88473 injection
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Non-Alcoholic Fatty Liver Disease, Liver Disease; Alcohol-Related
FibroScan-Reproducibility and Repeatability Study
Chronic liver disease (CLD) is a serious health issue worldwide, often progressing without symptoms until advanced stages with risks of complications like liver cancer and cirrhosis.
- Trial name
- FibroScan-RR (NCT06877026)
- Testing
- FibroScan, Liver Enzymes
- Where
- United Kingdom
- Volunteers
- 108 people
- Sponsor
- Echosens
Hepatocellular Carcinoma, Biliary Tract Cancer
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
- Trial name
- NCT05775159
- Testing
- Volrustomig, Bevacizumab, Lenvatinib
- Where
- 46 sites in United States, China and 7 more
- Volunteers
- 294 people
- Sponsor
- AstraZeneca
NASH, NAFLD
Phase Ib/II Study to Evaluate the Efficacy and Safety of GH509 Versus Placebo in Patients With NASH/NAFLD
This is a Phase Ib/II, randomized, double-blind, placebo-controlled, international multi-center clinical study to investigate the efficacy and safety of GH509 in subjects with NASH/NAFLD
- Trial name
- NCT05784779
- Testing
- GH509
- Where
- China
- Volunteers
- 180 people
- Sponsor
- 1Globe Biomedical Co., Ltd.
Non-Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages…
- Trial name
- NCT02466516
- Testing
- SEL, SIM
- Where
- 28 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).
- Trial name
- NCT04857606
- Testing
- AMG 609
- Where
- 10 sites in United States
- Volunteers
- 47 people
- Sponsor
- Amgen
Alpha 1-Antitrypsin Deficiency
A Study of Belcesiran in Patients With AATLD
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).
- Trial name
- ESTRELLA (NCT04764448)
- Testing
- Belcesiran
- Where
- 23 sites in United States, Australia and 12 more
- Volunteers
- 16 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Metabolic Dysfunction-Associated Steatoic Liver Disease
A Phase 2a Study of Kylo-0603 Capsule in Participants With Metabolic Dysfunction Associated Steatotic Liver Disease (MASLD)
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a metabolic stress-related liver injury closely associated with insulin resistance, with a global prevalence of approximately 25%.
- Trial name
- NCT07878091
- Testing
- Kylo 0603 Capsule 8mg, Kylo 0603 Capsule 12mg, Kylo 0603 Capsule 16mg
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NCT03823703
- Testing
- Miricorilant
- Where
- 15 sites in United States
- Volunteers
- 12 people
- Sponsor
- Corcept Therapeutics
Hepatic Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01767103
- Testing
- Ferriprox®
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Liver Diseases
A Research Study on Etavopivat in Participants With and Without Liver Disease
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls).
- Trial name
- NCT06336018
- Testing
- Etavopivat
- Where
- 5 sites in United States
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Nonalcoholic Fatty Liver, Weight Loss
Study on GS300 on NAFLD
To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).
- Trial name
- REVERT (NCT04887766)
- Testing
- GS300
- Volunteers
- 250 people
- Sponsor
- Gelesis, Inc.