Clinical trials: Biliary Stasis
Primary Biliary Cholangitis (PBC)
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT06755541
- Testing
- Fenofibrate in Combination With Ursodeoxycholic Acid
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
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
Primary Biliary Cholangitis
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT05749822
- Testing
- Fenofibrate 200mg, UDCA
- Where
- 12 sites in China
- Volunteers
- 104 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Biliary Atresia, Kasai
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG).
- Conditions
- Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
- Trial name
- NCT07250854
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Primary Biliary Cholangitis (PBC)
eMPower Mechanisms
Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life.
- Trial name
- NCT06861465
- Testing
- Online Mind-Body Wellness Program, Online Mind-Body Wellness Program + Nutritional Counselling
- Where
- Canada
- Volunteers
- 18 people
- Sponsor
- University of Alberta
Primary Biliary Cirrhosis
Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT01865812
- Testing
- Obeticholic Acid
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Intercept Pharmaceuticals
Primary Biliary Cholangitis
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
- Trial name
- NCT02516605
- Testing
- Part 1: LJN452, Part 2: LJN452 Dose level 1, Part 2: LJN452 Dose level 2
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Bile Duct Obstruction, Pancreatic Cancer
Biliary Metal Stent Study: Metal Stents for Management of Distal Malignant Biliary Obstruction
The primary purpose is to compare patency of two different types of biliary metal stents, i.e. covered versus uncovered Nitinella metal stent. Secondary purposes are to determine frequency of complications in the two groups, e.g.
- Conditions
- Bile Duct Obstruction, Pancreatic Cancer, Gallbladder Cancer, Bile Duct Cancer
- Trial name
- NCT00280709
- Testing
- "Nitinella" ; SX-ELLA Stent Biliary (biliary metal stent)
- Where
- Sweden
- Volunteers
- 400 people
- Sponsor
- University Hospital, Linkoeping
Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
Biobank for Cholestatic Liver Diseases.
This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis…
- Conditions
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma, Liver Cancer
- Trial name
- NCT03445585
- Where
- United States
- Volunteers
- 9,150 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
The primary biliary cholangitis (PBC), formerly known as primary biliary cirrhosis, treatment is based in the use of ursodeoxycholic acid (UDCA) at a daily dose of 13 to 15 mg/kg, without other treatment options.
- Trial name
- NCT02937012
- Testing
- Bezafibrate, Ursodeoxycholic Acid
- Where
- Mexico
- Volunteers
- 34 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Bile Duct Obstruction, Extrahepatic Cholestasis
Primary Versus Secondary Metal Stent Implantation in PTBD
The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.
- Trial name
- NCT04992585
- Testing
- Percutaneous transhepatic implantation of self-expandable metal stent
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Cystic Fibrosis, Gastrointestinal Diseases
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II.
- Conditions
- Cystic Fibrosis, Gastrointestinal Diseases, Cholestasis
- Trial name
- NCT00004315
- Testing
- ursodiol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Center for Research Resources (NCRR)
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Primary Biliary Cirrhosis
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02026401
- Testing
- NGM282
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- LEAP (NCT06193928)
- Testing
- Livmarli
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cirrhosis
A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04278820
- Testing
- TQA3526
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Heterozygous Haemoglobinopathy
Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies
This retrospective study aims to investigate pregnancy outcome in women with heterozygous hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections) and to analyze if there are aggravated…
- Trial name
- NCT03837119
- Testing
- pregnancy outcome
- Where
- 2 sites in Switzerland
- Volunteers
- 540 people
- Sponsor
- University Hospital, Basel, Switzerland
Alagille Syndrome, Pulmonary Artery Stenoses
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
The goal of this interventional study is to test a hemostasis screening protocol and cardiac peri-procedural and post-operative hemostasis pathway to improving bleeding complications and improve patient survival for children with…
- Conditions
- Alagille Syndrome, Pulmonary Artery Stenoses, Acquired Von Willebrand Disease
- Trial name
- NCT05846854
- Testing
- Assessment for bleeding disorder with tailored post-operative care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
Pediatric Cholestasis
A4250, an IBAT Inhibitor in Pediatric Cholestasis
This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus
- Trial name
- NCT02630875
- Testing
- A4250
- Where
- 7 sites in Denmark, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Albireo
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
The purpose of this study is to create a national, multi-centre registry for children with Alagille syndrome (ALGS) and Genetic Intrahepatic Cholestasis (GIC) that follows participants long-term, ensuring standardized…
- Conditions
- PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), Cholestasis, Intrahepatic
- Trial name
- PEARL (NCT07411716)
- Where
- 13 sites in Canada
- Volunteers
- 220 people
- Sponsor
- Children's Hospital of Eastern Ontario