Clinical trials: Biliary Cholestasis
Primary Biliary Cholangitis
A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life
Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.
- Trial name
- OCARELIFE (NCT03703076)
- Where
- 2 sites in France
- Volunteers
- 150 people
- Sponsor
- SAMEY
Progressive Familial Intrahepatic Cholestasis
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
Open-label extension study to evaluate long-term safety and persistence of effect of A4250 in children with progressive familial intrahepatic cholestasis (PFIC).
- Trial name
- PEDFIC 2 (NCT03659916)
- Testing
- A4250 (odevixibat)
- Where
- 41 sites in United States, Australia and 13 more
- Volunteers
- 116 people
- Sponsor
- Albireo, an Ipsen Company
Cholestasis
Linerixibat Long-term Safety, and Tolerability Study
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who…
- Trial name
- LLSAT (NCT04167358)
- Testing
- Linerixibat
- Where
- 94 sites in United States, Argentina and 15 more
- Volunteers
- 242 people
- Sponsor
- GlaxoSmithKline
Extrahepatic Cholestasis
Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to…
- Trial name
- NCT03237247
- Volunteers
- 38 people
- Sponsor
- Assiut University
Hereditary Diseases, Cholestasis, Intrahepatic
BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases
The purpose of the study is to improve the prognosis of inhereditary cholestasis caused by ABCB11 gene mutations by using BSEP function rescue drugs
- Trial name
- NCT04531878
- Testing
- 4-Phenylbutyrate
- Sponsor
- Children's Hospital of Fudan University
Bile Duct Obstruction
Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction
The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unresectable malignant bile duct…
- Trial name
- NCT00453076
- Testing
- Paclitaxel eluting covered metal stent and control covered metal stent
- Where
- South Korea
- Volunteers
- 52 people
- Sponsor
- Asan Medical Center
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis (PBC), Cirrhosis
PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.
Purpose The primary purpose is to use an imaging diagnostic method to examine how the medication for primary biliary cholangitis (PBC) works.
- Conditions
- Primary Biliary Cholangitis (PBC), Cirrhosis, Cholestasis, Ursodeoxycholic Acid
- Trial name
- NCT06604923
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- University of Aarhus
Obesity, Diabetes
Prediction Model for Early Biliary Stasis After Bariatric Surgery
Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery
- Conditions
- Obesity, Diabetes, Gallstones, Biliary Stasis
- Trial name
- PM-EBS-BS (NCT06385860)
- Volunteers
- 200 people
- Sponsor
- China-Japan Friendship Hospital
Primary Biliary Cholangitis
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- NCT06365424
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Cholestasis
Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children
Use of a fish oil emulsion to decrease liver disease due to long term intravenous nutrition.
- Trial name
- NCT01194063
- Testing
- Omega-3 fish oil lipid emulsion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Kapiolani Medical Center For Women & Children
SCAD, Addison Disease
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.
- Conditions
- SCAD, Addison Disease, Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome
- Trial name
- NCT03941184
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Mayo Clinic
Primary Biliary Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis (PSC)
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Trial name
- NCT06699121
- Testing
- LB-P8 low-dose, LB-P8 high-dose
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- LISCure Biosciences
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
Parenteral Nutrition-Associated Liver Disease
Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children
This is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with PN associated cholestasis.
- Trial name
- NCT02925520
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Cook Children's Health Care System
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
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects…
- Trial name
- NCT05190523
- Testing
- ASC42 5 mg, ASC42 10 mg, ASC42 15 mg
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Gannex Pharma Co., Ltd.
Biliary Atresia
Biliary Atresia Study in Infants and Children
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples…
- Trial name
- BASIC (NCT00345553)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,265 people
- Sponsor
- Arbor Research Collaborative for Health
Bile Duct Obstruction, Extrahepatic
Clinical Validation of an Immunocytochemistry Method Using MARS1
The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured.
- Trial name
- MARS1 (NCT04759794)
- Testing
- Cytology staining
- Where
- 5 sites in South Korea
- Volunteers
- 55 people
- Sponsor
- Gangnam Severance Hospital