Clinical trials: Hepatobiliary Diseases
Steatohepatitis
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT01154985
- Testing
- EPA-E 300 mg capsule
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 243 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Nonalcoholic Fatty Liver
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.
- Trial name
- NCT03763877
- Testing
- PXL770
- Where
- 15 sites in United States
- Volunteers
- 121 people
- Sponsor
- Poxel SA
Inborn Errors of Bile Acid Synthesis
Efficacy of To Be Marketed (TBM) Cholic Acid Capsules Used to Treat Children With Inborn Errors of Bile Acid Synthesis
This is a study in a small population of children who have inborn errors of bile acid synthesis who are currently taking established doses of the currently used cholic acid capsules prepared at the Cincinnati Children's Hospital…
- Trial name
- NCT01115582
- Testing
- Cholic acid
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Thrombocytopenia, Hepatitis C
Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C
This study will provide chronic hepatitis C patients with low platelets (less than 75x10^9/L) the opportunity to undergo treatment and possible cure of their virus.
- Trial name
- SQUELCH-C (NCT01821625)
- Testing
- Eltrombopag
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Texas Southwestern Medical Center
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.
Alcoholic Hepatitis
IL-1 Signal Inhibition in Alcoholic Hepatitis
Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver failure in the context of recent and heavy alcohol consumption.
- Trial name
- ISAIAH (NCT03775109)
- Testing
- Canakinumab 150mg/ml solution for injection
- Where
- 16 sites in United Kingdom
- Volunteers
- 55 people
- Sponsor
- Imperial College London
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
Chronic Hepatitis c, Cirrhosis, Liver
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to…
- Conditions
- Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis
- Trial name
- HALT-C (NCT00006164)
- Testing
- Peginterferon alfa-2a + Ribavirin, Peginterferon alfa-2a
- Where
- 11 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NASH - Nonalcoholic Steatohepatitis
Spironolactone Therapy In Young Women With NASH
Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years.
- Trial name
- NCT03576755
- Testing
- Spironolactone 100mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell
Project to Improve Communication About Serious Illness - Pilot Study
This two-year pilot study will test whether a one-page "Jumpstart Form" will affect goals-of-care discussions in the hospital. This form will be provided to clinicians and will include patient-specific information about…
- Conditions
- Malignant Neoplasm, Leukemia, Lymphocytic, Chronic, B-Cell, Lung Disease Chronic, Congestive Heart Failure
- Trial name
- PICSI-P (NCT03746392)
- Testing
- Jumpstart Intervention
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
Non-alcoholic Steatohepatitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Trial name
- BANFF (NCT04171765)
- Testing
- BFKB8488A
- Where
- 53 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- Genentech, Inc.
Overweight, Obese
The Effect of Protein-enriched Diet on Body Composition and Appetite
Obesity is a major problem worldwide and current dietary interventions are not proving to be enough to cease the increase in levels of obesity and its detrimental side effects, such as nonalcoholic fatty liver disease (NAFLD).
- Conditions
- Overweight, Obese, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease
- Trial name
- ProteinRich (NCT01634048)
- Testing
- High Protein, low calorie meal replacement
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Non-alcoholic Steatohepatitis
Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects…
- Trial name
- SyNCH (NCT00680407)
- Testing
- Silymarin 700 mg, Silymarin 420 mg
- Where
- 6 sites in United States
- Volunteers
- 78 people
- Sponsor
- Madaus Inc
HIV Infections, Non-Alcoholic Fatty Liver Disease
Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)
The purpose of this study was to evaluate the effects of semaglutide on intra-hepatic triglyceride (IHTG) content in people living with HIV (PLWH), central adiposity, insulin resistance or pre-diabetes, and hepatic steatosis.
- Trial name
- NCT04216589
- Testing
- Semaglutide
- Where
- 9 sites in United States, Brazil
- Volunteers
- 51 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Nonalcoholic Fatty Liver Disease (NAFLD)
Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
This study will advance several goals of the NIH Action Plan: 1) establish a multidisciplinary team to develop quantitative methodologies and imaging protocols for liver, 2) validate diagnostic criteria and methodologies for…
- Trial name
- NCT01930123
- Testing
- intravenous fructose challenge, Blood Draw
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Manal F Abdelmalek
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Trial name
- STELLAR-3 (NCT03053050)
- Testing
- SEL
- Where
- 298 sites in United States, Argentina and 25 more
- Volunteers
- 808 people
- Sponsor
- Gilead Sciences
Non-Alcoholic Fatty Liver Disease, Hepatitis B
A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada
(1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD in Canada do not have immunity to hepatitis B.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Hepatitis B, Vaccine Reaction
- Trial name
- NCT02985450
- Testing
- Engerix-B
- Where
- Canada
- Volunteers
- 82 people
- Sponsor
- University of Calgary
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