Clinical trials: Hepatobiliary Disorders
Fatty Liver
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E
Background: Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes.
- Trial name
- NCT01792115
- Testing
- Vitamin E 200 IU/d, Vitamin E 400 IU/d, Vitamin E 800 IU/d
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Non-alcoholic Steatohepatitis NASH
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH
The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH
- Trial name
- NCT02913105
- Testing
- LMB763
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
PCOS, Adolescent Obesity
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
Girls with obesity and polycystic ovarian syndrome will receive either glucagon like peptide-1 receptor agonist therapy or a dietary intervention for 12 weeks to decrease the metabolic syndrome, in particular to lower hepatic fat…
- Conditions
- PCOS, Adolescent Obesity, NAFLD
- Trial name
- TEAL (NCT03919929)
- Testing
- Semaglutide 3mg and 7mg [Rybelsus], Weight loss diet
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Colorado, Denver
HIV Infections, Hepatitis C
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and…
- Conditions
- HIV Infections, Hepatitis C, Liver Disease
- Trial name
- NCT00078403
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 333 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Liver Diseases
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy…
- Trial name
- BLOCS (NCT03245580)
- Testing
- Core Liver Biopsy
- Where
- 7 sites in United States
- Volunteers
- 153 people
- Sponsor
- Parkview Health
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Liver Disease
A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
This is a prospective dose escalation study of the administration of adult human stem cells in patients with end stage liver failure.
- Trial name
- NCT00655707
- Testing
- Autologous Expanded CD34+ Haemopoietic cells
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Nonalcoholic Steatohepatitis (NASH)
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02854605
- Testing
- GS-9674
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 140 people
- Sponsor
- Gilead Sciences
Non-alcoholic Fatty Liver Disease
Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver disease that can lead to cirrhosis and liver-related…
- Trial name
- NCT01963845
- Testing
- Sitagliptin
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of California, San Diego
End Stage Liver Disease, Decompensated Cirrhosis of Liver
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e.
- Trial name
- PAL-LIVER (NCT03540771)
- Testing
- Palliative Care
- Where
- 19 sites in United States
- Volunteers
- 1,494 people
- Sponsor
- Albert Einstein Healthcare Network
Minimal Hepatic Encephalopathy
Study of Lactulose in Children With Chronic Liver Disease
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will…
- Trial name
- MHE (NCT00811434)
- Testing
- Lactulose
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Indiana University
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
Liver Disease
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery.
- Trial name
- NCT01324349
- Testing
- Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
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.
End-stage Liver Disease (ESLD), Liver Transplant
A Physical Activity Program in End-state Liver Disease
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness
- Trial name
- NCT02776553
- Testing
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
Chronic HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT01938430
- Testing
- LDV/SOF, RBV
- Where
- 30 sites in United States
- Volunteers
- 339 people
- Sponsor
- Gilead Sciences
NASH - Nonalcoholic Steatohepatitis
Phase 2a Study of HPG1860 in Subjects With NASH
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
- Trial name
- RISE (NCT05338034)
- Testing
- HPG1860
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Hepagene (Shanghai) Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT04521114)
- Testing
- leronlimab 700 mg, leronlimab 350 mg
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- CytoDyn, Inc.