Clinical trials: Hepatobiliary Disorders
Non-Alcoholic Fatty Liver Disease
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic…
- Trial name
- NCT01285362
- Testing
- Fish Oil Supplementation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Columbia University
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Urea Cycle Disorder
Chronic Liver Disease in Urea Cycle Disorders
This is a pilot, cross-sectional study to assess liver stiffness and markers of hepatic injury, function, and fibrosis in patients with urea cycle disorders.
- Trial name
- NCT03721367
- Testing
- Diagnostic Ultrasound
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Baylor College of Medicine
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 Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- NCT04800094
- Testing
- Investigational Liver Fat Quantification Software
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Fatty Liver
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
- Trial name
- TONIC (NCT00063635)
- Testing
- Metformin, Vitamin E
- Where
- 10 sites in United States
- Volunteers
- 173 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Nonalcoholic Fatty Liver Disease (NAFLD)
Anti-LPS Antibody Treatment for Pediatric NAFLD
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver…
- Trial name
- NCT03042767
- Testing
- IMM-124E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Miriam Vos, MD
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.
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Ultrasound Method to Measure Fibrosis of the Liver in Children
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection, HBV
- Trial name
- NCT02086708
- Testing
- Shear Wave sonoelastography
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Massachusetts General Hospital
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
Non-Alcoholic Fatty Liver Disease, Insulin Resistance
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis
This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).
- Conditions
- Non-Alcoholic Fatty Liver Disease, Insulin Resistance, High Intensity Interval Training, Childhood Obesity
- Trial name
- NCT04342390
- Testing
- High-Intensity Interval Training (HIIT)
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Arkansas Children's Hospital Research Institute
Morbid Obesity, Obstructive Sleep Apnea Syndrome
LAGB as a Treatment for Morbid Obesity in Adolescents
Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older.
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance
- Trial name
- NCT01045499
- Testing
- Laparoscopic adjustable gastric banding (Allergan Lap Band)
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Jeffrey L Zitsman, MD
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
Parenteral Nutrition Associated Liver Disease
Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease
Babies in the newborn intensive care unit who are dependent upon intravenous nutrition for a long period of time frequently develop liver damage. The fat used is called intralipid and is made from soybean oil.
- Trial name
- NCT00862446
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Vanderbilt University Medical Center
Nonalcoholic Fatty Liver Disease (NAFLD)
Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD).
- Trial name
- CyNCh (NCT01529268)
- Testing
- DR cysteamine bitartrate capsule
- Where
- 10 sites in United States
- Volunteers
- 169 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated…
- Conditions
- Fatty Liver Disease, Nonalcoholic, Nonalcoholic Steatohepatitis, Lipodystrophy
- Trial name
- NCT01679197
- Testing
- Metreleptin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of Michigan
Pediatric Obesity, NAFLD
Effect of Obesity on Proton Pump Inhibitors
This longitudinal study tests the hypothesis that obesity affects drug pharmacology of acid suppression medications in children.
- Conditions
- Pediatric Obesity, NAFLD, GERD
- Trial name
- LiverLabPPI (NCT04248335)
- Testing
- Lansoprazole, Pantoprazole, Midazolam
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City
Cholestasis
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions.
- Trial name
- NCT02357576
- Testing
- Intralipid 20% I.V. Fat Emulsion
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- University of Michigan