Clinical trials: Biliary Cholestasis
Primary Biliary Cirrhosis
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression…
- Trial name
- NCT04751188
- Testing
- Bezafibrate 200 MG Oral Tablet, Ursodeoxycholic Acid
- Where
- Mexico
- Volunteers
- 11 people
- Sponsor
- Instituto Mexicano del Seguro Social
Biliary Tract Disease, Bile Duct Obstruction
Endo-biliary Laser Excision of Biliary Stenoses
The biliary system normally empties into the intestines, however, some patients have biliary system narrow areas ("stenosis") that prevent the bile to drain normally.
- Trial name
- NCT02118493
- Testing
- Benign Biliary Stenosis, Laser
- Sponsor
- University of Florida
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
- Trial name
- PBC-Phase 2 (NCT02943447)
- Testing
- Cilofexor
- Where
- 25 sites in United States, Austria and 2 more
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
Primary Biliary Cholangitis
Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives.
- Trial name
- RESCAT (NCT05919433)
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Hospital Mutua de Terrassa
Bile Duct Obstruction, Extrahepatic
Ultrasound-guided Percutaneous Biliary Drainage With Primary Metal Implantation by Endoscopic Luminal Guidance
In a recently published meta-analysis (Sharaiha, Gastrointestinal Endoscopy, 2017), it is reported that percutaneous transhepatic biliary drainage (PTBD) is less clinical successful, causes more adverse events and needs more…
- Trial name
- NCT03541590
- Testing
- Percutaneous transhepatic biliary drainage
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Biliary Tract Neoplasms, Pancreatic Neoplasms
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction
Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus.
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Stent Occlusion
- Trial name
- NCT00980889
- Testing
- Steel, Nitinol
- Where
- 11 sites in Sweden
- Volunteers
- 400 people
- Sponsor
- Stockholm South General Hospital
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
PBC
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression
Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver…
- Trial name
- NCT07733882
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Alagille Syndrome
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
- Trial name
- NCT07585097
- Where
- 14 sites in France, Italy
- Volunteers
- 30 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis
ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid…
- Trial name
- NCT03602560
- Testing
- seladelpar 5-10 mg, seladelpar 10 mg
- Where
- 156 sites in United States, Argentina and 21 more
- Volunteers
- 265 people
- Sponsor
- Gilead Sciences
Biliary Stricture, Pancreas Cancer
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria.
- Conditions
- Biliary Stricture, Pancreas Cancer, Cholangiocarcinoma, Bile Duct Cancer
- Trial name
- VLE-IOV (NCT03951324)
- Testing
- Interobserver agreement or Interrater agreement
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Innovative Digestive Health Education and Research Inc
Progressive Familial Intrahepatic Cholestasis
Gastrostomy-Biliary Diversion: Innovative Management for Bile Canalicular Transport Disorders
Progressive familial intrahepatic cholestasis (PFIC) is a group of disorders that can present early in life with cholestasis and intractable pruritus.
- Trial name
- NCT04071197
- Testing
- Gastostomy-biliary tube, External biliary diversion, internal biliary diversion and nasobiliary tube
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- National Liver Institute, Egypt
Cholestasis, Extrahepatic
Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents
Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be…
- Trial name
- NCT02114320
- Testing
- EUS-BD
- Where
- 2 sites in South Korea
- Volunteers
- 32 people
- Sponsor
- Asan Medical Center
Primary Biliary Cirrhosis
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis.
- Trial name
- NCT01603199
- Testing
- High protein high fiber diet
- Where
- Mexico
- Volunteers
- 36 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Primary Biliary Cirrhosis
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
Nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in Japan, and in May 2015 the use of nalfurafine hydrochloride was officially approved in Japan for pruritus in patients with chronic liver diseases…
- Trial name
- NCT02659696
- Where
- Japan
- Volunteers
- 44 people
- Sponsor
- Teikyo University
Intrahepatic Cholestasis of Pregnancy
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy
The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of…
- Trial name
- NCT01898832
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
Parenteral Nutrition, Necrotizing Enterocolitis
Neurodevelopment and Neuroimaging in Parenterally-fed Infants and Young Children
Manganese (Mn) is an essential metal required for normal growth and development. However, exposure to high Mn levels can be toxic to the brain.
- Conditions
- Parenteral Nutrition, Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392730
- Testing
- Remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Dental Diseases
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years.
- Trial name
- SMILE (NCT06506734)
- Testing
- Questionnaires
- Where
- 9 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Toulouse