Clinical trials: Liver Fibrosis/NASH
NAFLD, Liver Fibroses
Liver Damage and Cardiometabolic Disorders in NAFLD
Liver fibrosis is the most important prognostic factor in patients with non-alcoholic factor disease. Clinical and biological condition, as diabetes or mutation for PNPLA3, are well known factors associated with liver fibrosis…
- Conditions
- NAFLD, Liver Fibroses, Cardiovascular Diseases, Cardiovascular Risk Factor
- Trial name
- PLINIO (NCT04036357)
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- University of Roma La Sapienza
NAFLD
Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD
This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors.
- Trial name
- Cardio-NASH (NCT04774302)
- Where
- 2 sites in France
- Volunteers
- 292 people
- Sponsor
- Clinique Pasteur
Non-alcoholic Steatohepatitis, Fatty Liver
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
- Conditions
- Non-alcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis
- Trial name
- NCT03656068
- Testing
- Nitazoxanide 500mg BID
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Pinnacle Clinical Research, PLLC
Non-alcoholic Fatty Liver Disease
Non-invasive Diagnostic Model of Liver Fibrosis Associated With NAFLD and Prediction of Prognosis
In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver…
- Trial name
- NCT03842748
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
HCC, Cirrhosis, Liver
Use of Blood Biomarkers for the Early Diagnosis of Hepatocellular Carcinoma (HCC)
The objective of this observational study is to evaluate the clinical utility of the combined assay of 3 biomarkers: α-FP, α-FP-L3 and DCP (simultaneously measured by µTASWakoTM i30 automated in vitro diagnostic system) in…
- Conditions
- HCC, Cirrhosis, Liver, NAFLD, HBV
- Trial name
- GALAD (NCT05781568)
- Testing
- Biomarker dosage
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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
Nonalcoholic Fatty Liver Disease
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
- Trial name
- NCT04766476
- Testing
- BMS-963272
- Where
- 19 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bristol-Myers Squibb
Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
- Trial name
- PROXYMO-ADV (NCT05364931)
- Testing
- Cotadutide
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Hepatitis
Treating Nonalcoholic Steatohepatitis With Pioglitazone
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol.
- Trial name
- NCT00062764
- Testing
- Actos (Pioglitazone)
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver…
- Trial name
- NCT07631637
- Testing
- ALN-CIDEB
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Regeneron Pharmaceuticals
Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
Chronic Hepatitis b, Non-Alcoholic Fatty Liver Disease
Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis
Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled.
- Trial name
- NCT05786963
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Beijing Friendship Hospital
NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH
The study includes 52 weeks, double-blind treatment period. Clinic visits will occur at Randomization and every four weeks from Week 4 through Week 52 and through End of Study period.
- Trial name
- VOYAGE (NCT04173065)
- Testing
- VK2809
- Where
- 79 sites in United States, Belgium and 3 more
- Volunteers
- 248 people
- Sponsor
- Viking Therapeutics, Inc.
Metabolic Syndrome
Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of the metabolic syndrome of insulin resistance.
- Trial name
- NCT00399932
- Where
- Belgium
- Volunteers
- 75 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Obesity, NASH - Nonalcoholic Steatohepatitis
Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH
The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.
- Conditions
- Obesity, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Trial name
- NCT03538236
- Testing
- Intragastric balloon, Lifestyle intervention
- Sponsor
- Johns Hopkins University
Morbid Obesity, Diabetes
Bariatric Surgery and Fatty Liver Disease
The study is based on data from morbidly obese patients who fulfilled the criteria for bariatric surgery during 2016-2018 at the Department of Surgery, University Hospital Ostrava, Czech Republic.
- Conditions
- Morbid Obesity, Diabetes, Hypertension
- Trial name
- NCT04569396
- Testing
- Biochemistry analysis, NAFLD fibrosis score, BMI measurement
- Where
- Czechia
- Volunteers
- 72 people
- Sponsor
- University Hospital Ostrava
Non-alcoholic Steatohepatitis, Fibrosis
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist.
- Conditions
- Non-alcoholic Steatohepatitis, Fibrosis, Liver Diseases
- Trial name
- ENCORE-NF (NCT02686762)
- Testing
- Emricasan (5 mg), Emricasan (50 mg)
- Where
- 103 sites in United States, Germany and 1 more
- Volunteers
- 318 people
- Sponsor
- Conatus Pharmaceuticals Inc.
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.
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD
1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker 2. To develop non-invasive diagnosis marker for NASH and advanced fibrosis
- Trial name
- NCT03725631
- Testing
- Imaging and serologic evaluation of fibrosis and steatosis
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Korea University Guro Hospital
Liver Fibrosis
Screening of Liver Fibrosis in Adults Without Known Liver Disease
SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty…
- Trial name
- SIRIUS (NCT05486767)
- Testing
- Transient elastography
- Where
- 3 sites in Slovakia
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica