Clinical trials: Hepatic Fibrosis
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Sonoelastography: Ultrasound Method to Measure Liver Fibrosis
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, Hepatitis C Virus (HCV) Coinfection, Hepatitis B Virus (HBV)
- Trial name
- NCT01747772
- Testing
- Shear Wave Sonoelastography
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Massachusetts General Hospital
Portal Hypertension, Liver Cirrhosis
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients
This placebo-controlled study will assess the safety and efficacy of a 90-day course of treatment with ifetroban for portal hypertension in cirrhotic patients
- Trial name
- NCT02802228
- Testing
- Ifetroban
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Cumberland Pharmaceuticals
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
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
Liver Fibrosis, Liver Inflammation
Ultrasound Based Acoustic Radiation Force Impulse Imaging
ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.
- Trial name
- NCT01781208
- Testing
- Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Liver Cirrhosis
A Study to Compare How Different Substances (Caffeine, Warfarin, Omeprazole, Metoprolol, and Midazolam) Are Handled by the Body of Healthy People and People With Liver Cirrhosis
This study is open to healthy adults and adults with liver cirrhosis. The purpose of this study is to compare how different medicines are handled by the body in people with and without liver cirrhosis.
- Trial name
- NCT05741385
- Testing
- Caffeine, Warfarin sodium, Omeprazole
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Boehringer Ingelheim
Cirrhosis
A Trial to Improve Quality of Life in People With Cirrhosis
This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic…
- Trial name
- NCT05061992
- Testing
- Lactulose
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Michigan
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC
Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT04594694
- Testing
- Obeticholic acid, Bezafibrate 200 MG, Bezafibrate 400 MG
- Where
- 33 sites in Australia, Belgium and 15 more
- Volunteers
- 75 people
- Sponsor
- Intercept Pharmaceuticals
Nonalcoholic Steatohepatitis
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M…
- Trial name
- FORTUNA (NCT05809934)
- Testing
- AZD2693
- Where
- 163 sites in United States, Argentina and 20 more
- Volunteers
- 220 people
- Sponsor
- AstraZeneca
Liver Cirrhosis, Hypertension, Portal
PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors)
This study is aimed at investigating the effect of PPIs on gastroesophageal varices in liver cirrhosis. Half of participants will receive PPI, while the other half will receive a placebo.
- Trial name
- PPIs (NCT03175731)
- Testing
- Proton Pump Inhibitors
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Yanjing Gao
Cirrhosis
A Trial to Investigate the Efficacy of OPC-41061 Administered at a Dose of 7.5 mg in Patients With Hepatic Edema
OPC-41061 at 7.5 mg/day or placebo will be orally administered once daily for 7 days to cirrhosis patients with ascites despite having received treatment with conventional diuretics and the change in body weight from baseline at…
- Trial name
- NCT01050530
- Testing
- OPC-41061
- Where
- 8 sites in Japan
- Volunteers
- 162 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Liver Fibrosis, Liver Steatosis
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis.
- Trial name
- NCT03957070
- Testing
- Liver Incyte
- Where
- 2 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Sonic Incytes
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Hypertension, Portal, Liver Cirrhosis
A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes.
- Trial name
- NCT06082843
- Testing
- Avenciguat
- Where
- 15 sites in United States, Austria and 8 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Hepatic Encephalopathy, Cirrhosis
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
This study is being done to find out if the laxative polyethylene glycol (also known as GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely…
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Portosystemic Encephalopathy, PSE
- Trial name
- PSE (NCT01283152)
- Testing
- Polyethylene glycol 3350-electrolyte solution (GoLYTELY®), Lactulose
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Texas Southwestern Medical Center
Liver Cirrhosis, Portal Hypertension
Early TIPS for Ascites Study
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and…
- Conditions
- Liver Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT01236339
- Testing
- TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP, TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Liver Failure, Liver Diseases, Alcoholic
BRIDGE Device for Post-operative Pain Control
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity.
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative
- Trial name
- BRIDGE (NCT03265249)
- Testing
- BRIDGE device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Duke University
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.