Clinical trials: Bile Duct Obstruction
Biliary Cirrhosis, Primary
Family Studies in Primary Biliary Cirrhosis (PBC)
Primary biliary cirrhosis (PBC) is a chronic liver disease primarily affecting middle age women. It is characterized by immune-mediated damage to cells lining the tiny bile ducts within the liver.
- Trial name
- NCT00242125
- Where
- Canada
- Volunteers
- 3,000 people
- Sponsor
- University Health Network, Toronto
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
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis (PBC)
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC).
- Trial name
- NCT07631442
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
Bile Duct Obstruction
A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered.
- Trial name
- NCT03628001
- Testing
- ERCP
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Clinico Humanitas
Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone
SpyGlass AMEA Registry
The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of…
- Conditions
- Biliary Stricture, Biliary Obstruction Due to Common Bile Duct Stone, Periampullary Tumor, Hemobilia
- Trial name
- NCT02281019
- Testing
- ERCP (Endoscopic Retrograde Cholangiopancreatography), SpyGlass DVS and SpyGlass Digital Simple (DS)
- Where
- 20 sites in Australia, Hong Kong and 8 more
- Volunteers
- 526 people
- Sponsor
- Boston Scientific Corporation
Pruritus
J-LINX: Japan LINerixibat eXtension Study
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and…
- Trial name
- NCT07860710
- Testing
- Linerixibat
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis (PBC)
Probiotics in PBC Patients of Poor Response to UDCA
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
- Trial name
- NCT03521297
- Testing
- Probiotic
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Liver Cirrhosis, Biliary
Ursodiol-Methotrexate for Primary Biliary Cirrhosis
The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective than treatment with UDCA alone.
- Trial name
- NCT00006168
- Testing
- Methotrexate
- Where
- 12 sites in United States
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Cirrhosis, Biliary
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
- Trial name
- NCT00550862
- Testing
- INT-747, Ursodeoxycholic Acid (URSO)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 165 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
Phase I Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury
- Trial name
- NCT06888115
- Testing
- CS0159
- Where
- 3 sites in China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cascade Pharmaceuticals, Inc
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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 Cholangitis
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104.
- Trial name
- NCT05104853
- Testing
- CNP-104
- Where
- 19 sites in United States
- Volunteers
- 42 people
- Sponsor
- COUR Pharmaceutical Development Company, Inc.
Cholangiocarcinoma, Bile Duct Obstruction
Endoscopic Biliary RFA of Malignant Bile Duct Obstruction
Endoscopic radiofrequency ablation (RFA) is a new palliation therapy for malignant bile duct obstruction. It delivers a high amount of thermal energy to target tissue and may prolong the duration of stent patency.
- Trial name
- NCT02582541
- Testing
- SEMS alone, SEMS plus radiofrequency ablation
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The Second Hospital of Nanjing Medical University
Progressive Familial Intrahepatic Cholestasis
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion
The natural course of PFIC syndromes and the effect of diversion techniques, have so far not been characterized in a rigorous manner within a larger population of patients.
- Trial name
- NAPPED (NCT03930810)
- Testing
- Surgical biliary diversion
- Where
- Netherlands
- Volunteers
- 1,500 people
- Sponsor
- University Medical Center Groningen
Primary Biliary Cholangitis
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2.
- Trial name
- NCT06371196
- Testing
- Babaodan Capsule
- Volunteers
- 60 people
- Sponsor
- Mei Han
Primary Biliary Cirrhosis
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.
- Trial name
- NCT03590886
- Testing
- total response Group
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-sen University
Progressive Familial Intrahepatic Cholestasis
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
This registry-based study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) who take odevixibat (Bylvay) as part of routine clinical care in China.
- Trial name
- NCT07588880
- Where
- 6 sites in China
- Volunteers
- 20 people
- Sponsor
- Ipsen