Clinical trials: Biliary Stasis
Liver Disease
Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease
Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition.
- Trial name
- NCT02452177
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shengxian Fan
Bile Duct Obstruction, Extrahepatic
Development of a New Immunochemistry Method Using Antibodies of Proteins Related Bile Duct Cancer
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured.
- Trial name
- NCT03708445
- Testing
- Cytology staining
- Where
- 6 sites in South Korea
- Volunteers
- 240 people
- Sponsor
- Gangnam Severance Hospital
Cholestasis
Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers
This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects.
- Trial name
- NCT02801981
- Testing
- GSK2230672
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Primary Biliary Cholangitis (PBC)
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone…
- Trial name
- NCT07304843
- Testing
- golexanolone
- Where
- 38 sites in Germany, Greece and 6 more
- Volunteers
- 207 people
- Sponsor
- Umecrine Cognition AB
Primary Biliary Cholangitis
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid…
- Trial name
- NCT07282353
- Testing
- 2mg CS0159
- Where
- 42 sites in China
- Volunteers
- 135 people
- Sponsor
- Cascade Pharmaceuticals, Inc
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
Liver Cirrhosis, Biliary, Biliary Cirrhosis, Primary
Identification of the Genetic Variants Responsible for Primary Biliary Cirrhosis (PBC)
Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women. It causes slowly progressive liver disease, which eventually causes liver failure, requiring a liver transplant.
- Trial name
- NCT00145964
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- University Health Network, Toronto
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Intrahepatic Cholestasis of Pregnancy, Genetic Mutation
Bile Acids Metabolism and Genetic Mutation Profile in the Intrahepatic Cholestasis of Pregnacy in Indian Population
Intrahepatic cholestasis of pregnancy (ICP) is a disorder characterized by itching, elevated fasting serum bile acids ≥10μmol/L (and elevated serum transaminases), with increased risks of perinatal complications, including…
- Conditions
- Intrahepatic Cholestasis of Pregnancy, Genetic Mutation, Health Related Quality of Life
- Trial name
- ICP (NCT05691036)
- Where
- India
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Bile Salt Export Pump (BSEP) Transporter, Polysorbate 80
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
The study employs two-sub-studies that share a common placebo arm. The objective of one sub-study is to assess the impact of metformin on pravastatin and chenodeoxycholic acid pharmacokinetics.
- Trial name
- NCT04640571
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Parenteral Nutrition Associated Cholestasis
Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis
The study will evaluate the safety and efficacy of an intravenous fish oil emulsion (omegaven) in infants with parenteral nutrition associated cholestasis.
- Trial name
- NCT01601652
- Testing
- Omegaven
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Arthur J De Lorimier
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
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
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
Choledocholithiasis, Common Bile Duct Neoplasms
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic…
- Conditions
- Choledocholithiasis, Common Bile Duct Neoplasms, Cholestasis
- Trial name
- SAC (NCT01683240)
- Testing
- cholangioscopy (Frimberger)
- Where
- 5 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Liver Disease, Cholestasis
Gabapentin to Treat Itch in Patients With Liver Disease
In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York (NY).
- Conditions
- Liver Disease, Cholestasis, Cirrhosis, Pruritus
- Trial name
- NCT00058890
- Testing
- Gabapentin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT03353454
- Testing
- Maralixibat
- Sponsor
- Mirum Pharmaceuticals, Inc.
Bile Duct Obstruction
Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters
Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain…
- Trial name
- FLUSH (NCT04915703)
- Testing
- Flushing of PTBD catheter
- Where
- Netherlands
- Volunteers
- 38 people
- Sponsor
- Erasmus Medical Center