Clinical trials: Liver Fibroses
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- NCT06493253
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- United States
- Volunteers
- 1,519 people
- Sponsor
- PharmaNest, Inc
Hepatocellular Carcinoma, Hepatocellular Cancer
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatitis B, Cirrhosis
- Trial name
- NCT05064553
- Testing
- Study CT/MRI Imaging, Standard of Care CT/MRI Imaging, Oncoguard™ Liver Test
- Where
- 76 sites in United States
- Volunteers
- 2,990 people
- Sponsor
- Exact Sciences Corporation
Chronic Hepatitis B-related Liver Fibrosis
A Study of Hydronidone Capsules in Patients With Chronic Hepatitis B Virus-Related Liver Fibrosis
This trial employs a single-arm, open-label, multicenter clinical trial design. All study participants who meet the inclusion/exclusion criteria will receive Hydronidone treatment for 4 weeks.
- Trial name
- NCT07417553
- Testing
- Hydronidone capsules
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Liver Cirrhosis, Hepatic Cirrhosis
A Study of IDN-6556 in Cirrhotic Subjects With Portal Hypertension
This is an open-label pilot study to evaluate the safety, tolerability, and efficacy of IDN-6556 in treating portal hypertension in subjects with liver cirrhosis.
- Conditions
- Liver Cirrhosis, Hepatic Cirrhosis, Portal Hypertension
- Trial name
- PH (NCT02230683)
- Testing
- IDN-6556
- Where
- 16 sites in United States
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who…
- Trial name
- NCT02346721
- Testing
- SOF/VEL
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study of Resmetirom in Children and Adolescents With MASH
This study will evaluate the safety, pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the drug), and pharmacodynamics (how the drug affects the body) of resmetirom in children and adolescents with…
- Trial name
- NCT07763015
- Testing
- Resmetirom
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Hepatic Impairment, Cirrhosis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease
- Conditions
- Hepatic Impairment, Cirrhosis, Cholestatic Liver Disease
- Trial name
- NCT05045482
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zydus Therapeutics Inc.
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Liver Cirrhosis, Fibrosis
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical…
- Conditions
- Liver Cirrhosis, Fibrosis, Liver Disease, Digestive System Disease
- Trial name
- NCT01483248
- Testing
- conventional therapy plus MenSC transplantation
- Where
- China
- Volunteers
- 50 people
- Sponsor
- S-Evans Biosciences Co., Ltd.
Hepatitis C
BreathID Multi-center HCV Liver Breath Test Study
The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (>2 in METAVIR) in patients with chronic…
- Trial name
- NCT00350714
- Testing
- MBT and BreathID
- Where
- 5 sites in United States, Israel
- Volunteers
- 75 people
- Sponsor
- Meridian Bioscience, Inc.
Acute on Chronic Hepatic Failure
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate.
- Trial name
- HEPATICUS-1 (NCT01079091)
- Testing
- ADVOS (Hepa Wash), Standard Medical Therapy
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- Hepa Wash GmbH
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.
Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
- Trial name
- CENTRICITY (NCT05623189)
- Testing
- HTD1801
- Where
- 45 sites in United States, Hong Kong and 1 more
- Volunteers
- 218 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis…
- Trial name
- NCT04048876
- Testing
- CC-90001
- Where
- 142 sites in United States, Australia and 8 more
- Volunteers
- 56 people
- Sponsor
- Celgene
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Hepatic Cirrhosis, Ascites
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.
- Trial name
- NCT01359462
- Testing
- tolvaptan
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Otsuka Beijing Research Institute
Portal Hypertension
Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance.
- Trial name
- NCT00414869
- Testing
- NCX-1000
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Forest Laboratories