Clinical trials: Cholestasis
Cholestasis in Newborn, Biliary Atresia
The Dirty Nappy Study
This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns.
- Conditions
- Cholestasis in Newborn, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT07697872
- Where
- United Kingdom
- Volunteers
- 5,350 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's and Children's NHS Foundation Trust
Cholestasis
Omegaven® as Parenteral Nutrition
The purpose of this study is to determine if a fat emulsion comprised of omega-3 fatty acids, Omegaven, would be beneficial in the management of steatotic liver injury in parenteral nutrition (PN) by its inhibition of de novo…
- Trial name
- NCT02334293
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Carle Foundation 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
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.
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Cholestasis
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the…
- Trial name
- NCT00004410
- Testing
- tauroursodeoxycholic acid
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Neonatal Cholestasis, Total Parenteral Nutrition Effect
Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)
The aim of this study is to evaluate the risk factors of PNAC in neonates
- Trial name
- TPN (NCT05163145)
- Testing
- TPN
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mayyada Elsayed Mohamed Hussien
Cholestasis, Liver Disease
Compassionate Use of Omegaven IV Fat Emulsion
This protocol involves the compassionate use of intravenous fish oil infusion, Omegaven. The protocol involves infants and children with parenteral nutrition-associated liver disease to enable the reversal of elevated serum liver…
- Trial name
- NCT02477345
- Testing
- Omegaven IV
- Where
- United States
- Sponsor
- Northwell Health
Neonatal Cholestasis
Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis
The stool color scale was set in 2018 in the health books of French children. The study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.
- Trial name
- NCT06048211
- Testing
- Stool color scale
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Central Hospital, Nancy, France
Intrahepatic, Cholestasis
Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions
Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN).
- Trial name
- NCT02633384
- Testing
- SMOFlipid, Lipofundin
- Volunteers
- 52 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
This study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this…
- Conditions
- Parenteral Nutrition Associated Liver Disease, Essential Fatty Acid Deficiency, Neurocognitive Deficit, Malnutrition
- Trial name
- NCT04807478
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Sponsor
- Fresenius Kabi
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
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Cholestasis
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
- Trial name
- URSONEONAT (NCT00846963)
- Testing
- Ursodiol
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Ibrahim Mohamed
Total Parenteral Nutrition-induced Cholestasis
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
- Trial name
- NCT02534077
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Pediatrix
Progressive Familial Intrahepatic Cholestasis
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
Open-label extension study to evaluate long-term safety and persistence of effect of A4250 in children with progressive familial intrahepatic cholestasis (PFIC).
- Trial name
- PEDFIC 2 (NCT03659916)
- Testing
- A4250 (odevixibat)
- Where
- 41 sites in United States, Australia and 13 more
- Volunteers
- 116 people
- Sponsor
- Albireo, an Ipsen Company
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
Hereditary Diseases, Cholestasis, Intrahepatic
BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases
The purpose of the study is to improve the prognosis of inhereditary cholestasis caused by ABCB11 gene mutations by using BSEP function rescue drugs
- Trial name
- NCT04531878
- Testing
- 4-Phenylbutyrate
- Sponsor
- Children's Hospital of Fudan University
Parenteral Nutrition-Associated Liver Disease
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis.
- Trial name
- NCT02925520
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Cook Children's Health Care System
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda