Clinical trials: Hepatobiliary Diseases
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.
Liver Inflammation, Fatty Liver Disease
LivQ-box® Parameters in the Diagnosis of Liver Inflammation
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
- Trial name
- NCT06802731
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Wuxi Hisky Medical Technology Co Ltd
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
- 22 sites in United States, Puerto Rico
- Volunteers
- 104 people
- Sponsor
- AstraZeneca
Chronic Liver Disease, Thrombocytopenia
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.
- Trial name
- L-PLUS 2 (NCT02389621)
- Testing
- Lusutrombopag
- Volunteers
- 215 people
- Sponsor
- Shionogi
Liver Disease
Hepatic Impairment Study
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose.
- Trial name
- NCT00829231
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 3 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bayer
Non-Alcoholic Steatohepatitis (NASH)
Phase 2b Study in NASH to Assess IVA337
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common.
- Trial name
- NATIVE (NCT03008070)
- Testing
- IVA337
- Where
- 85 sites in United States, Australia and 14 more
- Volunteers
- 247 people
- Sponsor
- Inventiva Pharma
Liver Diseases, Liver Cirrhosis
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
Early screening and monitoring of chronic liver diseases in hepatology practice has become crucial. To achieve this goal, hepatology clinics need simple and available tools at the point-of-care to perform disease severity…
- Conditions
- Liver Diseases, Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease
- Trial name
- DIACEPA (NCT04782050)
- Testing
- Ultrasound liver assessment
- Where
- France
- Volunteers
- 100 people
- Sponsor
- E-Scopics
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Healthy
Investigating the Effects of a High GI Versus a Low GI Diet on Hepatic Metabolism and Satiety Levels in Healthy Subjects
The aim of this study is to investigate the effect of a one week high versus low glycaemic index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a two way cross overs study and to see if…
- Trial name
- NCT02482558
- Testing
- High/Low Glycaemic index test breakfast
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty…
- Trial name
- NCT07527910
- Testing
- ALN-PNP, Tirzepatide
- Where
- 9 sites in United States
- Volunteers
- 204 people
- Sponsor
- Regeneron Pharmaceuticals
Hepatitis C
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders…
- Trial name
- ECLIPSE 3 (NCT01024894)
- Testing
- Interleukin-7
- Where
- 4 sites in Taiwan
- Volunteers
- 15 people
- Sponsor
- Cytheris SA
Non-Alcoholic Fatty Liver Disease
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
A double-blind placebo controlled randomized Phase 3 study to evaluate the safety and tolerability of once-daily, oral administration of 80 or 100 mg resmetirom versus matching placebo.
- Trial name
- MAESTRO-NAFLD1 (NCT04197479)
- Testing
- Resmetirom
- Where
- 77 sites in United States, Puerto Rico
- Volunteers
- 1,343 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Liver Transplant; Complications, NAFLD
Safety, Tolerability, and Efficacy of Saroglitazar Mg 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (NAFLD)
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
- Trial name
- NCT03639623
- Testing
- Saroglitazar
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Zydus Therapeutics Inc.
NASH - Nonalcoholic Steatohepatitis
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects.
- Trial name
- NCT04972396
- Testing
- Pemvidutide, Metformin, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
Non-Alcoholic Steatohepatitis
A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)
- Trial name
- NCT04378010
- Testing
- EDP-305 1.5 mg, EDP-305 2 mg
- Where
- 81 sites in United States, Argentina and 4 more
- Volunteers
- 98 people
- Sponsor
- Enanta Pharmaceuticals, Inc
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
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Liver Disease
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
- Trial name
- MBT (NCT00736840)
- Testing
- c13 methacetin solution with breath analyzer
- Where
- 11 sites in United States, Israel
- Volunteers
- 414 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatic Impairment
Hepatic Impairment, Cholestatic Liver Disease, & NASH with Advanced Fibrosis & Normal Hepatic Function
This will be a Phase 1, Open-label Study of Participants with Hepatic Impairment, Cholestatic Liver Disease, and NASH with Advanced Fibrosis and Normal Hepatic Function
- Trial name
- NCT04469920
- Testing
- Saroglitazar Magnesium 2 mg, Saroglitazar Magnesium 4 mg
- Where
- 2 sites in United States
- Volunteers
- 98 people
- Sponsor
- Zydus Therapeutics Inc.
Hepatitis C
Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
- Trial name
- ECLIPSE 1 (NCT01025596)
- Testing
- Interleukin-7
- Where
- 7 sites in France, Italy and 1 more
- Volunteers
- 10 people
- Sponsor
- Cytheris SA