Clinical trials: Biliary Cholestasis
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 Cirrhosis
The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland
PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking.
- Trial name
- NCT02846896
- Where
- Switzerland
- Volunteers
- 501 people
- Sponsor
- Fondazione Epatocentro Ticino
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury
The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.
- Trial name
- NCT02780193
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Rush University Medical Center
Intrahepatic Cholestasis, Pregnancy
Ursodeoxycholic Acid in the Treatment of Intrahepatic Cholestasis of Pregnancy
The purpose of this study is to examine the efficacy and safety of ursodeoxycholic acid (UDCA) in the treatment of patients with intrahepatic cholestasis of pregnancy (ICP).
- Trial name
- NCT01576458
- Testing
- ursodeoxycholic acid
- Where
- Finland
- Volunteers
- 20 people
- Sponsor
- Turku University 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
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis (PBC), Primary Biliary Cholangitis
Biochemical Response and Clinical Outcomes in Patients With PBC
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics…
- Trial name
- NCT07449793
- Testing
- Only observation
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- RenJi Hospital
PBC, Primary Biliary Cholangitis
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
The German PBC Cohort is a multi-centric, observational (non-interventional) study with three parallel groups. The main objective of this observational study is to describe the course of Primary biliary cholangitis (PBC) in…
- Trial name
- PBC-Cohort (NCT04076527)
- Testing
- UDCA, Ocaliva
- Where
- 50 sites in Germany
- Volunteers
- 1,200 people
- Sponsor
- University of Leipzig
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
Primary Biliary Cholangitis, Spleen Stiffness
The Value of Spleen Stiffness Measurement in Patients With PBC
Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC.
- Trial name
- NCT07319169
- Testing
- Spleen stiffness measurement
- Where
- Belgium
- Volunteers
- 125 people
- Sponsor
- Universitair Ziekenhuis Brussel
Primary Biliary Cholangitis, Primary Sclerosing Cholangitis
The Effect of Bezafibrate on Cholestatic Itch
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
- Conditions
- Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
- Trial name
- FITCH (NCT02701166)
- Testing
- Bezafibrate
- Where
- 9 sites in Netherlands, Spain
- Volunteers
- 84 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Cholestatic Liver Disease, Intrahepatic Cholestasis
Genotype-phenotype Relationship Between Cryptogenic Cholestasis and Familial Intrahepatic Cholestasis
Genotype-phenotype relationship between adult cryptogenic cholestasis and mutations in genes responsible for progressive familial intrahepatic cholestasis
- Conditions
- Cholestatic Liver Disease, Intrahepatic Cholestasis, Progressive Familial Intrahepatic Cholestasis, Hepatobiliary Cancer
- Trial name
- NCT06781242
- Where
- 2 sites in Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Cholestasis, Intrahepatic
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
This will be a randomized, double-blind, placebo-controlled study to assess safety and tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC) and symptoms of pruritus.
- Trial name
- NCT01899703
- Testing
- GSK2330672, Ursodeoxycholic acid
- Where
- 3 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis (PBC)
Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response…
- Trial name
- NCT03124108
- Testing
- Elafibranor 80 mg, Elafibranor 120 mg
- Where
- 24 sites in United States, France and 3 more
- Volunteers
- 45 people
- Sponsor
- Genfit
Primary Biliary Cholangitis
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis.
- Trial name
- UDCA PBC (NCT04650243)
- Testing
- ursodeoxycholic acid
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Peking Union Medical College Hospital
Primary Biliary Cholangitis
The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis
The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis.
- Trial name
- NCT06309589
- Testing
- Vitamin D
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Yilihamu·Abilitifu
Primary Biliary Cholangitis
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT05239468
- Testing
- Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg
- Where
- 26 sites in United States, Argentina and 2 more
- Volunteers
- 72 people
- Sponsor
- Intercept Pharmaceuticals
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
Biliary Stasis, Extrahepatic
The Effect of Aspirin on Patency of Metal Stent in Malignant Distal Bile Duct Obstruction
The aim of this study is to determine whether administration of aspirin can help maintain the patency of metallic stents for distal malignant common bile duct obstruction.
- Trial name
- NCT03279809
- Testing
- Aspirin
- Where
- South Korea
- Volunteers
- 52 people
- Sponsor
- Woo Hyun Paik