Clinical trials: Biliary Cholestasis
Primary Biliary Cholangitis, Compensated Cirrhosis
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.
A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.
- Trial name
- NCT06525311
- Testing
- K-808
- Where
- 10 sites in United States, Japan
- Volunteers
- 17 people
- Sponsor
- Kowa Research Institute, Inc.
Primary Biliary Cirrhosis
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis
- Trial name
- NCT03665519
- Testing
- Sublimated mare milk, Ursodeoxycholic Acid
- Where
- Kazakhstan
- Volunteers
- 40 people
- Sponsor
- National Scientific Medical Center, Kazakhstan
Malignant Tumor of Extrahepatic Bile Duct
Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct.
- Trial name
- NCT01514214
- Testing
- WInged perimeter biliary stent insertion (Viaduct), traditional polyethylene stent insertion (Cotton Huibregtse)
- Where
- 2 sites in Canada
- Volunteers
- 58 people
- Sponsor
- University of British Columbia
Total Parenteral Nutrition-induced Cholestasis
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated…
- Trial name
- NCT01845116
- Testing
- Omegaven®
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Wake Forest University Health Sciences
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.
Intrahepatic Cholestasis of Pregnancy
Maralixibat for Intrahepatic Cholestasis of Pregnancy
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
- Trial name
- METAPHOR (NCT07389031)
- Testing
- Maralixibat
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful.
- Trial name
- NCT06694038
- Testing
- Needle Knife Fistulotomy, standard biliary cannulation
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Thomas Jefferson University
Distal Bile Duct Obstruction
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct…
- Trial name
- NCT01905384
- Testing
- Covered Self-expanding metal biliary stents (C-SEMS), Uncovered Self-expanding metal biliary stents (U-SEMS)
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vanderbilt University Medical Center
Primary Biliary Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC.
- Trial name
- ELONSEN (NCT06730061)
- Testing
- Elafibranor
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar…
- Trial name
- NCT07841977
- Testing
- Seladelpar, PTM Seladelpar, Cilofexor Dose B
- Where
- 4 sites in United States
- Volunteers
- 132 people
- Sponsor
- Gilead Sciences
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
Bile Duct; Obstruction, With Calculus, Choledocholithiasis
Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage
Cholelithiasis occurs in 10-20% of the general population. Up to 18% of these subjects will present symptoms. In patients with symptomatic choledocholithiasis who are not candidates for surgery with indication for ERCP…
- Trial name
- PECAS (NCT03921502)
- Testing
- Gall bladder transmural drainage with LAMS
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Hospital del Rio Hortega
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
Biliary Atresia
Tolerability of Enteral NAC in Infants
Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation.
- Trial name
- NCT06260566
- Testing
- N-Acetylcysteine
- Volunteers
- 12 people
- Sponsor
- Sanjiv Harpavat
Biliary Atresia, Alagille Syndrome
FibroScan™ in Pediatric Cholestatic Liver Disease (FORCE)
Noninvasive monitoring of liver fibrosis is an unmet need within the clinical management of pediatric chronic liver disease. While liver biopsy is often used in the initial diagnostic evaluation, subsequent biopsies are rarely…
- Conditions
- Biliary Atresia, Alagille Syndrome, Alpha1 Anti-Trypsin Deficiency, Portal Hypertension
- Trial name
- FORCE (NCT02922751)
- Testing
- Liver Stiffness Measurement (LSM)
- Where
- 13 sites in United States, Canada
- Volunteers
- 552 people
- Sponsor
- Arbor Research Collaborative for Health
Primary Biliary Cirrhosis
Moexipril for Primary Biliary Cirrhosis
The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE)…
- Trial name
- NCT00588302
- Testing
- Moexipril
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis, Hypercholesterolemia
Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and possibly with an increased cardiovascular morbidity and mortality.
- Trial name
- NCT00844402
- Testing
- Atorvastatin
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Graz
Mirizzi Syndrome, Cholelithiasis
Treatment of Mirizzi Syndrome
Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the…
- Conditions
- Mirizzi Syndrome, Cholelithiasis, Acute Cholecystitis
- Trial name
- NCT04672902
- Testing
- Single-operator cholangioscopy guided electrohydraulic lithotripsy
- Where
- Mexico
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Tecnologico de Monterrey
Biliary Tract Neoplasms, Jaundice, Obstructive
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents
Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction.
- Trial name
- NCT01315522
- Testing
- ComVi stent, Uncovered SEMS
- Where
- 3 sites in South Korea
- Volunteers
- 43 people
- Sponsor
- Seoul National University Hospital
Primary Biliary Cholangitis (PBC)
RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis
The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary…
- Trial name
- RELIEF (NCT07161245)
- Testing
- Multimodal prehabilitation, standard of care
- Where
- Spain
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hospital Clinic of Barcelona