Clinical trials: Biliary Cholestasis
Autoimmune Liver Disease, Autoimmune Hepatitis
TruGraf Liver Gene Expression Serial Test
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months…
- Conditions
- Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
- Trial name
- NCT06061341
- Testing
- TruGraf®
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Washington University School of Medicine
Cholestasis in Newborn, Biliary Atresia
The Dirty Nappy Study
This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns.
- Conditions
- Cholestasis in Newborn, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT07697872
- Where
- United Kingdom
- Volunteers
- 5,350 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's and Children's NHS Foundation Trust
Primary Biliary Cholangitis (PBC), Long-term Outcomes
PBC Long-term Outcomes Study
Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of…
- Conditions
- Primary Biliary Cholangitis (PBC), Long-term Outcomes, Prognosis, Multicenter Prospective Study
- Trial name
- NCT07149675
- Where
- China
- Volunteers
- 4,000 people
- Sponsor
- Beijing Friendship Hospital
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
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
Cholestasis, Red Cell Membrane and Enzyme Abnormalities
Osmotic Fragility in Red Blood Cells of Pediatric Patients With Cholestatic Liver Disease
Objective: The investigators propose to perform ektacytometry on 20 pediatric patients over age one with cholestatic liver diseases and a direct bilirubin level of greater than 2 gm/dl.
- Trial name
- NCT05582447
- Testing
- ektacytometry of red blood cells
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Primary Biliary Cirrhosis
Genetic Epidemiology of Primary Biliary Cirrhosis (PBC)
Primary Biliary Cirrhosis (PBC) is a progressive liver disorder of unknown cause. Current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an…
- Trial name
- NCT01161953
- Testing
- Genetic Analysis
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Mayo Clinic
Primary Biliary Cholangitis
A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA
This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).
- Trial name
- NCT03742973
- Testing
- Baricitinib
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
LEOPARD Prospective Validation Cohort 1
Intro: The present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT)…
- Conditions
- Decompensated Liver Cirrhosis, Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Hepato-cellular Carcinoma
- Trial name
- LEOPARD PVC1 (NCT06723275)
- Testing
- Standardized assessments, guided tumor biopsy and biobanking, Standardized assessments and biobanking
- Where
- 8 sites in Belgium, France and 3 more
- Volunteers
- 630 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Bile Duct Obstruction, Disorder of Bile Duct Stent
The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.
- Conditions
- Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
- Trial name
- NCT01862198
- Testing
- EUS-guided biliary drainage with a hybrid metallic stent
- Where
- 2 sites in South Korea
- Volunteers
- 27 people
- Sponsor
- Inje University
PFIC - Progressive Familial Intrahepatic Cholestasis
A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain
Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of inherited conditions that affect how bile moves in the liver, which can lead to serious liver problems.
- Trial name
- REGENIC (NCT07191704)
- Where
- 10 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Ipsen
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Pruritus, Primary Biliary Cholangitis
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.
- Trial name
- NCT06733519
- Testing
- Nalmefene
- Volunteers
- 40 people
- Sponsor
- Tharimmune Inc
Primary Biliary Cholangitis
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- EPICS-III (NCT05133336)
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- 57 sites in United States, Argentina and 2 more
- Volunteers
- 196 people
- Sponsor
- Zydus Therapeutics Inc.
Premature Birth
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene…
- Trial name
- TPNAC (NCT01062724)
- Testing
- Primene 10 % from Baxter
- Where
- Mexico
- Volunteers
- 94 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Carcinomas/Neoplasms
Evolution® Biliary Stent System-Fully Covered
The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms…
- Trial name
- NCT02104076
- Testing
- Evolution® Biliary Stent-Fully Covered
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Cook Group Incorporated
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