Clinical trials: Biliary Cholestasis
PBC, Primary Biliary Cirrhosis
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with…
- Trial name
- CLARITY (NCT01904058)
- Testing
- LUM001, Ursodeoxycholic Acid
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 66 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hepatobiliary Cancers, Progressive Familial Intrahepatic Cholestasis (PFIC)
Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers
This is a cross-sectional, multicenter tissue study with an exploratory aim to estimate the prevalence of genetic mutations that predispose individuals to diseases in the context of cholestatic disorders and hepatobiliary…
- Conditions
- Hepatobiliary Cancers, Progressive Familial Intrahepatic Cholestasis (PFIC), Cholestatic Liver Disease
- Trial name
- NCT06777914
- Where
- 5 sites in Italy
- Volunteers
- 600 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Primary Biliary Cholangitis
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT03155932
- Testing
- APD334
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 2 people
- Sponsor
- Arena Pharmaceuticals
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
Primary Biliary Cholangitis
National Database on Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy.
- Trial name
- PBC322 (NCT05151809)
- Testing
- Clinical information
- Where
- 55 sites in Italy
- Volunteers
- 6,000 people
- Sponsor
- University of Milano Bicocca
Cholestasis, Extrahepatic
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
- Trial name
- NCT00433771
- Testing
- WallFlex™ Biliary Fully Covered Metal Stent placement
- Where
- 10 sites in United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Cholestatic Liver Disease, Chronic Liver Disease (CLD)
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
The goal of this clinical trial is to learn whether adding calcitriol to vitamin D2 can improve vitamin D deficiency in children with cholestasis and chronic liver disease.
- Conditions
- Cholestatic Liver Disease, Chronic Liver Disease (CLD), Vitamin D Deficiency, Children
- Trial name
- VITD-CHOL (NCT07670611)
- Testing
- Vitamin D2, Calcitriol
- Where
- Thailand
- Volunteers
- 54 people
- Sponsor
- Chulalongkorn University
Cholestasis
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.
- Trial name
- FO (NCT00969332)
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of California, Los Angeles
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
Primary Biliary Cirrhosis
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT03301506
- Testing
- Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
- Where
- 109 sites in United States, Argentina and 23 more
- Volunteers
- 340 people
- Sponsor
- Gilead Sciences
Biliary Anastomotic Stricture, Biliary Tract Diseases
Magnetic Compression Anastomosis for Recanalization of Biliary Stricture
Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly…
- Conditions
- Biliary Anastomotic Stricture, Biliary Tract Diseases, Cholestasis, Extrahepatic, Endotoxicosis
- Trial name
- NCT04170933
- Testing
- Magnetic recanalization
- Where
- China
- Volunteers
- 60 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Cholangitis, Sclerosing, Liver Cirrhosis, Biliary
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II.
- Trial name
- NCT00004842
- Testing
- budesonide
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary Biliary Cirrhosis
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations.
- Trial name
- NCT02823353
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free…
- Trial name
- NCT02823366
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Pancreatic Cancer, Biliary Stasis
Cancer of the Head of the Pancreas: Early Surgery or Preoperative Biliary Drainage?
Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice.
- Trial name
- NCT03358095
- Testing
- Tannenbaum Fr 10 stent or WallFlex stent
- Where
- Finland
- Sponsor
- Helsinki University Central Hospital
Intrahepatic Cholestasis
Induction of Labor in Intrahepatic Cholestasis of Pregnancy
Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications.
- Trial name
- ILICP (NCT01381939)
- Volunteers
- 5,000 people
- Sponsor
- Karolinska Institutet
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Hepatobiliary Diseases
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases
The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases.
- Trial name
- NCT01200082
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Total Parenteral Nutrition-induced Cholestasis, Cholestasis
Compassionate Use of Omegaven in Children
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis
- Trial name
- NCT02370251
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Oklahoma
Primary Biliary Cirrhosis
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
- Trial name
- NCT01389973
- Testing
- ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Janssen Research & Development, LLC