Clinical trials: Biliary Stasis
Short Bowel Syndrome
Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off Total Parenteral…
- Trial name
- NCT01891279
- Testing
- elemental formula Elecare®, partially hydrolyzed formula
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center, Houston
Cholestasis, Progressive Familial Intrahepatic 3
Second-line Therapy of Unresectable Cholangiocarcinoma by RADIOEMBOLIZATION
Cholangiocarcinoma (CCK) is a rare tumor (2000 new cases/year in France) with very poor prognosis (overall survival < 3% at 5 years).
- Trial name
- CHOLANGIOSIR (NCT01383746)
- Testing
- Yttrium microsphere injection
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Pruritus
J-LINX: Japan LINerixibat eXtension Study
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and…
- Trial name
- NCT07860710
- Testing
- Linerixibat
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Autoimmune Hepatitis, Primary Biliary Cirrhosis
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine.
- Trial name
- NCT04933292
- Testing
- Methylprednisolone and Mycophenolate mofetil, Methylprednisolone and azathioprine
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Xiaoli Fan
Cholestatic Liver Disease, Progressive Familial Intrahepatic Cholestasis
DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE
Cholestatic disease in adults comprises a heterogeneous group of conditions characterized by intra- or extrahepatic alterations of bile flow that can lead to fibrosis or hepatic decompensation.
- Trial name
- FIRST (NCT07317193)
- Testing
- Advanced Whole Genome Sequencing to Identify Rare Pathogenic Variants in Unexplained Cholestatic Liver Disease
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Assessment of Physical Examination Skills for the Cardiovascular System, Determining Levels of Academic Self-Efficacy
Examining the Effects of ARCS-Based Education on Cardiovascular System Physical Examination Skills, Motivation, and Self-Efficacy Levels in Nursing Students
Objective: The purpose of this study is to determine the effect of ARCS-based nursing education on skill levels, motivation, and self-efficacy in the physical examination of the cardiovascular system.
- Conditions
- Assessment of Physical Examination Skills for the Cardiovascular System, Determining Levels of Academic Self-Efficacy, Determining Motivation Levels, Evaluation of the Effectiveness of the ARCS Intervention
- Trial name
- NCT07733479
- Testing
- ARCS Model Education, Structured Supplementary Training Based on the ARCS Motivation Model
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Cumhuriyet University
Primary Biliary Cholangitis (PBC)
RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary…
- Trial name
- RELIEF (NCT07161245)
- Testing
- Multimodal prehabilitation, standard of care
- Where
- Spain
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona
Intrahepatic Cholestasis of Pregnancy
Serum Bile Acid Profiles in Patients With Intrahepatic Cholestasis of Pregnancy
The goal of this observational study is to learn if analyzing bile acid patterns can help predict dangerous complications in pregnant women with intrahepatic cholestasis of pregnancy (ICP), a liver condition that can affect the…
- Trial name
- BAPP (NCT07428226)
- Where
- Germany
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Jena University Hospital
Cholestasis, Red Cell Membrane and Enzyme Abnormalities
Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease
Objective: The investigators propose to perform ektacytometry on 20 pediatric patients over age one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl.
- Trial name
- NCT05582447
- Testing
- ektacytometry of red blood cells
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Cholestasis, Neonatal Jaundice
Liver Biopsy in Diagnosis Neonatal Jaundice
1. Identification and characterization of histopathological features of liver in cases of PNJ. 2. Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic…
- Trial name
- NCT06628726
- Testing
- Liver biopsy
- Volunteers
- 50 people
- Sponsor
- Assiut University
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Cholestasis in Newborn
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN.
- Trial name
- NCT02692326
- Testing
- Cyclic parenteral nutrition
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
Cholestasis
A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).
- Trial name
- NCT00685386
- Testing
- CO2 insufflation, Room air insufflation
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of North Carolina, Chapel Hill
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated…
- Trial name
- NCT01412359
- Testing
- Omegaven®
- Where
- United States
- Sponsor
- Jeffrey Rudolph
Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas
Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
- Conditions
- Bile Duct Obstruction, Extrahepatic, Cancer of the Pancreas, Cancer of the Bile Duct, Biliary Stricture
- Trial name
- NCT03821025
- Testing
- Biliary stent
- Where
- South Africa
- Volunteers
- 150 people
- Sponsor
- University of Cape Town
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
- Conditions
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis, Cholestasis
- Trial name
- NCT07843420
- Testing
- Nemolizumab-ilto
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Gallstone, Bile Duct Obstruction
Treatment Outcomes in Bile Duct Stones
This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.
- Conditions
- Gallstone, Bile Duct Obstruction, Bile Duct Diseases
- Trial name
- NCT04145843
- Testing
- endoscopic retrograde cholangiopancreatography
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- AdventHealth
Primary Biliary Cholangitis
A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis
This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
- Trial name
- NCT03345589
- Testing
- 18-22mg/kg/d Ursodeoxycholic, 13-15mg/kg/d Ursodeoxycholic
- Where
- China
- Volunteers
- 40 people
- Sponsor
- West China Hospital