Clinical trials: Biliary Cirrhosis, Primary
Primary Biliary Cirrhosis
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver…
- Trial name
- ELATIVE (NCT04526665)
- Testing
- Elafibranor 80mg
- Where
- 115 sites in United States, Argentina and 12 more
- Volunteers
- 161 people
- Sponsor
- Ipsen
Primary Biliary Cirrhosis
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary…
- Trial name
- POISE (NCT01473524)
- Testing
- Obeticholic Acid (OCA)
- Where
- 59 sites in United States, Australia and 11 more
- Volunteers
- 217 people
- Sponsor
- Intercept Pharmaceuticals
Pruritus
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)
This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.
- Trial name
- NCT04950127
- Testing
- Linerixibat
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
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
PBC, Primary Biliary Cholangitis
Swiss Primary Biliary Cholangitis Cohort Study
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.
- Trial name
- NCT03146910
- Where
- 13 sites in Switzerland
- Volunteers
- 500 people
- Sponsor
- Fondazione Epatocentro Ticino
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.
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 Cirrhosis
Pentoxifylline for Primary Biliary Cirrhosis
Primary biliary cirrhosis (PBC) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications.
- Trial name
- NCT01249092
- Testing
- Pentoxifylline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Primary Biliary Cirrhosis
Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis
This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis
- Trial name
- NCT03665519
- Testing
- Sublimated mare milk, Ursodeoxycholic Acid
- Where
- Kazakhstan
- Volunteers
- 40 people
- Sponsor
- National Scientific Medical Center, Kazakhstan
Hepatitis, Primary Biliary Cholangitis
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with total glucosides of paeony in the treatment of PBC with AIH features 1
- Conditions
- Hepatitis, Primary Biliary Cholangitis, Autoimmune
- Trial name
- NCT04618575
- Testing
- Ursodeoxycholic acid combined with total glucosides of paeony, Ursodeoxycholic acid only
- Where
- China
- Volunteers
- 137 people
- Sponsor
- West China Hospital
Primary Biliary Cirrhosis
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high…
- Trial name
- NCT03226067
- Testing
- GKT137831
- Where
- 61 sites in United States, Belgium and 7 more
- Volunteers
- 111 people
- Sponsor
- Calliditas Therapeutics AB
Cirrhosis, Biliary Atresia
Predictive Models of Hepatic Decompensation and Survival Outcomes in Pediatric Patients With Cirrhosis
The aim of this study was to developed and validated models to predict hepatic decompensation and survivals in pediatric patients with cirrhosis and compared these models with currently available models.
- Conditions
- Cirrhosis, Biliary Atresia, Choledochal Cyst, Primary Sclerosing Cholangitis
- Trial name
- NCT05181332
- Testing
- Prediction model
- Where
- China
- Volunteers
- 400 people
- Sponsor
- West China Hospital
Liver Cirrhosis, Biliary
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II.
- Trial name
- NCT00004748
- Testing
- colchicine, methotrexate, ursodiol
- Volunteers
- 90 people
- Sponsor
- National Center for Research Resources (NCRR)
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
COVID-19 Infection
UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19.
- Trial name
- NCT05812612
- Testing
- ursodeoxycholic acid
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Beijing Ditan Hospital
Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC)
Deciphering the Self-antigen Specific T Cell Signature of Autoimmune Liver Diseases
The study aims to establish the molecular signature of autoimmune self-antigen-specific T cells in AutoImmune Liver Disease (AILD)
- Conditions
- Autoimmune Hepatitis, Primary Biliary Cholangitis (PBC), Autoimmune Liver Disease, Primary Sclerosing Cholangitis (PSC)
- Trial name
- DISTAL (NCT07784881)
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Nantes University Hospital
Primary Biliary Cirrhosis
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
- Trial name
- PIANO (NCT01430429)
- Testing
- NI-0801
- Where
- 2 sites in Italy, United Kingdom
- Sponsor
- Light Chain Bioscience - Novimmune SA
Primary Biliary Cirrhosis
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02135536
- Testing
- NGM282
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 36 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC)
The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching
Cholestatic liver diseases are characterized by jaundice, pruritus, and elevated levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT).
- Conditions
- Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC), Atopic Dermatitis (AD)
- Trial name
- NCT07678645
- Testing
- Upadacitinib 15 MG
- Where
- China
- Volunteers
- 44 people
- Sponsor
- RenJi Hospital
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.