Clinical trials: Cholestasis
Cholestasis
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.
- Trial name
- CHOLESTASE (NCT02767648)
- Testing
- proteomic urine analysis
- Where
- 4 sites in France
- Volunteers
- 57 people
- Sponsor
- University Hospital, Toulouse
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
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
Alagille Syndrome
Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review
Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right…
- Trial name
- NCT01515631
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Stanford University
Parenteral Nutrition Associated Liver Disease
Omegaven Expanded Access Protocol
Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole…
- Trial name
- NCT02121769
- Testing
- Omegaven
- Where
- United States
- Sponsor
- St. Luke's Health System, Boise, Idaho
Biliary Atresia, Alagille Syndrome
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely…
- Conditions
- Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension
- Trial name
- FORCE (NCT02922751)
- Testing
- Liver Stiffness Measurement (LSM)
- Where
- 13 sites in United States, Canada
- Volunteers
- 552 people
- Sponsor
- Arbor Research Collaborative for Health
Alagille Syndrome, Atorvastatin
Atorvastatin Therapy on Xanthoma in Alagille Syndrome
To observe the efficacy and safety of atorvastatin on xanthoma in Alagille syndrome through a prospective study.
- Conditions
- Alagille Syndrome, Atorvastatin, Xanthoma
- Trial name
- NCT05488067
- Testing
- atorvastatin
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Children's Hospital of Fudan University
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
Acute Liver Failure, Mitochondrial Diseases
Longitudinal Study of Mitochondrial Hepatopathies
The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating…
- Conditions
- Acute Liver Failure, Mitochondrial Diseases, End Stage Liver Disease, Respiratory Chain Deficiencies, Mitochondrial
- Trial name
- MITOHEP (NCT01148550)
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Arbor Research Collaborative for Health
Cholestasis
Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.
- Trial name
- NCT02148146
- Testing
- Omegaven
- Where
- 2 sites in United States
- Sponsor
- University of California, San Diego
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD
Cholestasis, Jaundice, Obstructive
SMOFlipid to Lessen the Severity of Neonatal Cholestasis
Parenteral nutrition (PN) provides intravenous nutritional supplementation for infants unable to absorb adequate enteral nutrients secondary to insufficient intestinal length or function.
- Trial name
- NCT02721277
- Testing
- SMOFlipid
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- University of Florida
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate 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 patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome
Cholestasis Reversal: Efficacy of IV Fish Oil
The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).
- Conditions
- Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome, Gastrointestinal Disease
- Trial name
- Reversal (NCT00910104)
- Testing
- Omegaven®
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Mark Puder
Cirrhosis, Liver Fibrosis
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis
Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive…
- Conditions
- Cirrhosis, Liver Fibrosis, Portal Hypertension, Cystic Fibrosis
- Trial name
- PEDISCAN (NCT01072721)
- Testing
- Elastometry
- Where
- France
- Volunteers
- 264 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Cholestasis
Fibrates in Pediatric Cholestasis
A study conducted to assess the effect of fibrates on pruritus and biochemical picture in pediatric patients with cholestatic liver diseases.
- Trial name
- NCT03586674
- Testing
- Lipanthyl, Ursogal
- Where
- 2 sites in Egypt
- Volunteers
- 50 people
- Sponsor
- Hoda A. Atta