Clinical trials: Bile Duct Obstruction
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.
Cholangitis, Secondary Biliary, Treatment Compliance
Antibiotics Treatment of Cholangitis Post-Kasai Portoenterostomy
Application of multi-center, prospective study on the severity of postoperative cholangitis biliary atresia classification, according to the degree of cholangitis targeted therapy, to improve the therapeutic effect of…
- Conditions
- Cholangitis, Secondary Biliary, Treatment Compliance, Antibodies Drug Specific
- Trial name
- NCT04370145
- Testing
- Sulperazon, Teicoplanin, Meropenem Injection
- Where
- 2 sites in China
- Volunteers
- 160 people
- Sponsor
- Tongji Hospital
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
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, Cholestasis of Parenteral Nutrition
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of 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
- NCT00738101
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 293 people
- Sponsor
- Baylor College of Medicine
Alagille Syndrome
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
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
Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
- Trial name
- PSC (NCT01802073)
- Testing
- Oral Vancomycin
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Stanford University
Total Parenteral Nutrition-Induced Cholestasis
Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
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
- NCT02328768
- Testing
- Omegaven
- Where
- United States
- Sponsor
- University of Nebraska
Biliary Atresia
A Prospective Database of Infants With Cholestasis
Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period.
- Trial name
- PROBE (NCT00061828)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- Arbor Research Collaborative for Health
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)
The main aim of the study is to check if TAK-625 improves symptoms of Progressive Familial Intrahepatic Cholestasis (PFIC), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543187
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Takeda
Cholestasis
Compassionate Use of Omegaven
This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously.
- Trial name
- NCT02778698
- Testing
- Omegaven
- Sponsor
- Geisinger Clinic
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
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
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
Cholestasis
Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid…
- Trial name
- NCT02663453
- Testing
- multicomponent lipid emulsion, pure soybean oil lipid emulsion
- Volunteers
- 44 people
- Sponsor
- Thammasat University
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 Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Choledocholithiasis With Cholecystitis With Obstruction, Choledocholithiasis With Acute and Chronic Cholecystitis
Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis
The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide.
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Choledocholithiasis With Acute and Chronic Cholecystitis, Cholelithiasis With Acute and Chronic Cholecystitis
- Trial name
- NCT04213092
- Testing
- ERCP+LC, OC+CBD
- Volunteers
- 160 people
- Sponsor
- Lumbini Medical College
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