Clinical trials: Biliary Stasis
Liver Cirrhosis, Biliary
Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia
- Trial name
- NCT03468699
- Testing
- Autologous BMMC transplantation
- Where
- 2 sites in Vietnam
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either…
- Trial name
- NCT01323907
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Sivan Kinberg
Primary Biliary Cirrhosis
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
- Trial name
- NCT01857284
- Testing
- Tauroursodeoxycholic Acid Capsules, Ursodeoxycholic Acid Capsules
- Where
- 25 sites in China
- Volunteers
- 216 people
- Sponsor
- Beijing Friendship Hospital
Fatigue, Primary Biliary Cirrhosis
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis
Primary Biliary Cirrhosis (PBC) is a liver disease that predominantly affects females, can present for the first time at any age and which develops over many years.
- Trial name
- RITPBC (NCT02376335)
- Testing
- Rituximab
- Where
- United Kingdom
- Volunteers
- 71 people
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
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
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
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
Primary Biliary Cirrhosis
Online Wellness Intervention for Primary Biliary Cholangitis (PBC)
Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic…
- Trial name
- NCT04791527
- Testing
- Mind-body therapy
- Where
- Canada
- Volunteers
- 34 people
- Sponsor
- University of Alberta
Primary Biliary Cirrhosis
Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia
Biliary atresia (BA) is the most frequent cause of chronic cholestasis in neonates, accounting for at least 50% of pediatric liver transplantation. BA incidence is estimated to range from 1:5000 to 1:19000 live births.
- Trial name
- UCMSCBA (NCT04522869)
- Testing
- Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation
- Where
- 2 sites in Vietnam
- Volunteers
- 20 people
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
Primary Biliary Cholangitis (PBC)
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a…
- Trial name
- ELFIDENCE (NCT06016842)
- Testing
- Elafibranor
- Where
- 198 sites in United States, Argentina and 26 more
- Volunteers
- 276 people
- Sponsor
- Ipsen
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University
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
PFIC - Progressive Familial Intrahepatic Cholestasis
Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
Progressive familial intrahepatic cholestasis (PFIC) is a rare inherited liver disease that causes a build-up of bile acids in the liver.
- Trial name
- OvEC-PFIC (NCT07497724)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Ipsen
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.
Intrahepatic Cholestasis of Pregnancy, Arrhythmia
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave…
- Trial name
- NCT01906827
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Primary Biliary Cholangitis, Heart Failure
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time.
- Conditions
- Primary Biliary Cholangitis, Heart Failure, Digestive Diseases, Women Who Have Experienced a Cardiac Event
- Trial name
- EMPOwer (NCT05786482)
- Testing
- Online mind-body wellness program, Online mind-body wellness program + Weekly Check-ins
- Where
- Canada
- Volunteers
- 825 people
- Sponsor
- University of Alberta
Progressive Familial Intrahepatic Cholestasis
Prospective Analysis of the Treatment of Progressive Familial Intrahepatic Cholestasis (TreatFIC)
The project has the following general aims: 1. Natural course and prognosis: To prospectively follow the natural course and prognosis of the different types of PFIC, to broaden the understanding of the different very rare…
- Trial name
- TreatFIC (NCT06778174)
- Testing
- observational study
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- University Medical Center Groningen