Clinical trials: NASH With Fibrosis
NAFLD, NASH
The European NAFLD Registry
The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and…
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver
- Trial name
- NCT04442334
- Where
- 37 sites in Belgium, Finland and 10 more
- Volunteers
- 10,000 people
- Sponsor
- Newcastle University
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver…
- Trial name
- NCT01694849
- Testing
- GFT505 80mg, GFT505 120mg
- Where
- 56 sites in United States, Belgium and 7 more
- Volunteers
- 275 people
- Sponsor
- Genfit
Non Alcoholic Steatohepatitis (NASH)
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis…
- Trial name
- NCT04880187
- Testing
- AXA1125
- Where
- 75 sites in United States, Australia and 5 more
- Volunteers
- 273 people
- Sponsor
- Axcella Health, Inc
Liver Diseases, Liver Cirrhosis
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
The main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with NASH, and to compare them to other…
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH - Nonalcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
- Trial name
- POCUS-NASH (NCT05120557)
- Testing
- Ultrasound liver assessment
- Volunteers
- 1,000 people
- Sponsor
- E-Scopics
NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver
A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver, NAFLD - Nonalcoholic Fatty Liver Disease
- Trial name
- AMBITION (NCT04480710)
- Testing
- CRV431 75mg, CRV431 225mg
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 47 people
- Sponsor
- Hepion Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic…
- Trial name
- RESOLVE-IT (NCT02704403)
- Testing
- Elafibranor
- Where
- 326 sites in United States, Argentina and 23 more
- Volunteers
- 2,157 people
- Sponsor
- Genfit
Non-alcoholic Steatohepatitis (NASH)
Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
The prevalence of non-alcoholic fatty liver disease (NAFLD ) in the American population is approximately 30% in adults and 10% in children, making it the most common. Cause of chronic liver disease in the United States.
- Trial name
- NCT05050721
- Testing
- CT imaging
- Where
- United States
- Sponsor
- Methodist Health System
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
NAFLD, NASH
THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)
The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis
- Trial name
- FRAMES (NCT04925362)
- Testing
- Biological specimens, Additional visit
- Volunteers
- 900 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
NAFLD, NASH
Validation of the LiverFASt Test and the Associated Fibrosis Staging Scores Compared to Liver Tissue Pathology Via Liver Biopsy
This study is to assess the diagnostic performance of the LiverFASt Test for assessing fibrosis staging scores compared to the assessment of liver tissue pathology from liver biopsy.
- Trial name
- NCT03980912
- Testing
- LiverFASt
- Where
- United States
- Sponsor
- Fibronostics USA, Inc
NAFLD - Nonalcoholic Fatty Liver Disease, Diabetes
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
The main aim of the study is to set up an observational cohort with NAFLD (Non-alcoholic fatty liver disease) at different stage of disease (from simple steatosis to cirrhosis and/or HCC-Hepatocellular carcinoma) and for…
- Conditions
- NAFLD - Nonalcoholic Fatty Liver Disease, Diabetes, Obesity, Metabolic Syndrome
- Trial name
- PROMETEO (NCT04371042)
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Non-alcoholic Steatohepatitis (NASH)
Endoscopic Bariatric Therapy in NASH Cirrhosis
Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma.
- Trial name
- ETHIC (NCT04281303)
- Testing
- Endoscopic vertical gastroplasty
- Volunteers
- 10 people
- Sponsor
- Instituto de Investigación Marqués de Valdecilla
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis
- Trial name
- NCT04255069
- Testing
- Dose 1 JKB-122, Dose 2 JKB-122
- Volunteers
- 300 people
- Sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
Liver Diseases, Liver Cirrhosis
Palliative Care for Non-Malignant Diseases (COMPASS Trial)
The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes…
- Conditions
- Liver Diseases, Liver Cirrhosis, NASH (Non-Alcoholic Steatohepatitis)
- Trial name
- COMPASS (NCT03022630)
- Testing
- Comprehensive Palliative Care services, Usual hepatic care
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Vanderbilt University Medical Center
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.
NAFLD, NASH - Nonalcoholic Steatohepatitis
A Self Selected Population Study of Undiagnosed NAFLD and NASH, Using an Echosens FibroScan, in at Risk Populations
Liver disease (NAFLD) and (NASH) are a rapidly increasing population health threat driven primarily by diet and lifestyle. Fibrotic liver disease, culminating in cirrhosis, is frequently asymptomatic so it is common for a patient…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver, Fatty Liver
- Trial name
- SUNN (NCT03726827)
- Testing
- Fibroscan screening
- Where
- United States
- Volunteers
- 1,006 people, healthy volunteers welcome
- Sponsor
- Fatty liver Foundation
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
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
Liver Fibrosis Due to NASH
Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH
The primary objective of this study is to evaluate the safety and efficacy of SIM (formerly referred to as GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT01672879)
- Testing
- SIM
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 259 people
- Sponsor
- Gilead Sciences