Clinical trials: Biliary Cholestasis
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Progressive Familial Intrahepatic Cholestasis
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion
The natural course of PFIC syndromes and the effect of diversion techniques, have so far not been characterized in a rigorous manner within a larger population of patients.
- Trial name
- NAPPED (NCT03930810)
- Testing
- Surgical biliary diversion
- Where
- Netherlands
- Volunteers
- 1,500 people
- Sponsor
- University Medical Center Groningen
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment.
- Trial name
- NCT07290257
- Testing
- Livmarli Oral Product
- Where
- 15 sites in Belgium, France and 6 more
- Volunteers
- 230 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis of Parenteral Nutrition
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may…
- Trial name
- NCT01861834
- Testing
- Omegaven 10%
- Where
- 2 sites in United States
- Sponsor
- Georgetown University
Cholestasis, Parenteral Nutrition Associated Liver Disease (PNALD)
Minimization of IntraLipid Versus Omegaven
Prolonged use of parenteral nutrition can lead to parenteral nutrition associated liver disease (PNALD). The purpose of this study is to determine the effect of treatment with a smaller amount lipid minimization) of our standard…
- Trial name
- MILOve (NCT01247012)
- Testing
- Omegaven, Lipid minimization
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Children's & Women's Health Centre of British Columbia
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
Cholestasis, Children
Retrospective Review of CT and MR in Pediatric Patients With Cholestasis
The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and the measurement of transverse diameters of…
- Trial name
- NCT01252043
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- National Taiwan University Hospital
Cholangitis
Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis.
- Trial name
- NCT01148693
- Testing
- gentamicin
- Where
- Iran
- Volunteers
- 114 people
- Sponsor
- Tehran University of Medical Sciences
Bile Duct Obstruction, Extrahepatic
Reconstruction of the Bile Duct With the Round Ligament
The investigators developed a new surgical technique in order to reconstruct the bile duct with the round ligament
- Trial name
- NCT03030573
- Testing
- Reconstruction of the bile duct with the round ligament
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Beaujon Hospital
Primary Biliary Cholangitis
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
- Trial name
- ELFINITY (NCT06447168)
- Where
- 72 sites in United States, Australia and 9 more
- Volunteers
- 424 people
- Sponsor
- Ipsen
Biliary Atresia
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.
- Trial name
- NCT05925543
- Testing
- Kasai portoenterostomy operation.
- Where
- Egypt
- Volunteers
- 45 people
- Sponsor
- Aswan University Hospital
Biliary Atresia, Kasai
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG).
- Conditions
- Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
- Trial name
- NCT07250854
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.
- Trial name
- NCT02780193
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Rush University Medical Center
Intrahepatic Cholestasis, Pregnancy
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT01576458
- Testing
- ursodeoxycholic acid
- Where
- Finland
- Volunteers
- 20 people
- Sponsor
- Turku University Hospital
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Liver Cirrhosis, Biliary
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia
- Trial name
- NCT03468699
- Testing
- Autologous BMMC transplantation
- Where
- 2 sites in Vietnam
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
Liver Disease
Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease
Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition.
- Trial name
- NCT02452177
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shengxian Fan
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University