Clinical trials: Biliary Cholestasis
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
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
Liver Disease
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative…
- Trial name
- Omegaven (NCT01425567)
- Testing
- Intravenous Lipid Emulsion Comprised of Fish Oil
- Where
- United States
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
Primary Biliary Cholangitis, Liver Fibrosis
Patients With Primary Biliary Cholangitis(PBC)
Primary Biliary Cholangitis (PBC) is a chronic autoimmune cholestatic liver disease characterized by the progressive destruction of small intrahepatic bile ducts, leading to chronic cholestasis, hepatic fibrosis, and, in advanced…
- Conditions
- Primary Biliary Cholangitis, Liver Fibrosis, Cirrhosis, Liver, Blood Sugar; High
- Trial name
- GLYPP (NCT07629128)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cholangitis
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients.
- Trial name
- NCT05751967
- Testing
- Fenofibrate Combined With Ursodeoxycholic Acid
- Where
- 7 sites in China
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
- Trial name
- NCT02965911
- Testing
- Fenofibrate, UDCA
- Where
- China
- Sponsor
- Beijing 302 Hospital
Alagille Syndrome
A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)
An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US.
- Trial name
- NCT04530994
- Testing
- maralixibat
- Where
- 14 sites in United States
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis, PBC
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible…
- Trial name
- VANTAGE (NCT05050136)
- Testing
- Volixibat
- Where
- 130 sites in United States, Argentina and 13 more
- Volunteers
- 333 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Periampullary Cancer, Complications of Surgical Procedures or Medical Care
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary…
- Conditions
- Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
- Trial name
- NCT01789502
- Testing
- Fully covered metal stents, Plastic stents
- Where
- 3 sites in South Korea
- Volunteers
- 86 people
- Sponsor
- Inje University
Liver Diseases, Alagille Syndrome
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)
Cholestasis is a condition in which bile is not properly transported from the liver to the small intestine. Cholestasis can be caused by an array of childhood diseases, including the genetic diseases Alagille syndrome (ALGS)…
- Conditions
- Liver Diseases, Alagille Syndrome, Alpha 1-Antitrypsin Deficiency
- Trial name
- LOGIC (NCT00571272)
- Where
- 17 sites in United States, Canada
- Volunteers
- 1,675 people
- Sponsor
- Arbor Research Collaborative for Health
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Primary Biliary Cirrhosis
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients
Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high titers of serum anti-mitochondrial…
- Trial name
- NCT02477462
- Testing
- Clinic visit, Baseline visit
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Cholestasis, Cholestasis of Parenteral Nutrition
Omegaven as Alternative Parenteral Fat Nutrition
To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis
- Trial name
- NCT03662282
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of South Florida
Cholestasis
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II.
- Trial name
- NCT00004414
- Testing
- sincalide
- Where
- 6 sites in United States
- Volunteers
- 252 people
- Sponsor
- University of Michigan
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for cancer of the bile duct, gallbladder, or pancreas.
- Conditions
- Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer
- Trial name
- NCT00003923
- Testing
- porfimer sodium
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Primary Biliary Cirrhosis
Pilot Study of FFP104 Dose Escalation in PBC Subjects
The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC
- Trial name
- NCT02193360
- Testing
- FFP104
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Fast Forward Pharmaceuticals
Hepatitis, Primary Biliary Cholangitis
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
- Conditions
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- Trial name
- NCT04618575
- Testing
- Ursodeoxycholic acid combined with total glucosides of paeony, Ursodeoxycholic acid only
- Where
- China
- Volunteers
- 137 people
- Sponsor
- West China Hospital
Pancreaticobiliary Cancers, Jaundice
Endoscopic Ultrasound Versus Endoscopic Retrograde Cholangiopancreatography (ERCP) Tissue Sampling for the Diagnosis of Suspected Pancreatico-Biliary Cancer
The two most commonly used methods to biopsy suspected pancreaticobiliary masses are (1) endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) and (2) cytology brush biopsies obtained during endoscopic retrograde…
- Conditions
- Pancreaticobiliary Cancers, Jaundice, Bile Duct Obstruction
- Trial name
- NCT01356030
- Testing
- ERCP, EUS FNA
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- California Pacific Medical Center Research Institute