Clinical trials: Biliary Cirrhosis, Primary
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
Primary Biliary Cholangitis (PBC)
Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC).
- Trial name
- NCT07631442
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stanford University
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
Primary Biliary Cirrhosis
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
- Trial name
- NCT02026401
- Testing
- NGM282
- Where
- 17 sites in United States, Australia
- Volunteers
- 45 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Primary Biliary Cholangitis
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients.
- Trial name
- NCT05751967
- Testing
- Fenofibrate Combined With Ursodeoxycholic Acid
- Where
- 7 sites in China
- Volunteers
- 150 people
- Sponsor
- Xijing Hospital of Digestive Diseases
Primary Biliary Cirrhosis
Study of Obeticholic Acid（OCA） Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion.
- Trial name
- NCT04956328
- Testing
- Obeticholic Acid Tablets, UDCA
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Primary Biliary Cirrhosis
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or…
- Trial name
- NCT02955602
- Testing
- MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Gilead Sciences
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 (PBC)
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.
- Trial name
- NCT07906639
- Testing
- Elafibranor
- Volunteers
- 50 people
- Sponsor
- Ipsen
Cirrhosis, Cirrhosis, Liver
Liver Cirrhosis Network Cohort Study
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis.
- Conditions
- Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B
- Trial name
- LCN-C (NCT05740358)
- Where
- 14 sites in United States
- Volunteers
- 1,222 people
- Sponsor
- Northwestern University
Biliary Cirrhosis, Primary
A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials.
- Trial name
- NCT02932449
- Where
- 39 sites in United States
- Volunteers
- 711 people
- Sponsor
- Target PharmaSolutions, Inc.
Chronic Liver Disease
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death.
- Trial name
- FALL (NCT05335603)
- Where
- Denmark
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- University of Copenhagen
Primary Biliary Cirrhosis
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients
Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high titers of serum anti-mitochondrial…
- Trial name
- NCT02477462
- Testing
- Clinic visit, Baseline visit
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
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 Cholangitis
National Database on Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy.
- Trial name
- PBC322 (NCT05151809)
- Testing
- Clinical information
- Where
- 55 sites in Italy
- Volunteers
- 6,000 people
- Sponsor
- University of Milano Bicocca
Autoimmune Hepatitis, Primary Biliary Cirrhosis
A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine.
- Trial name
- NCT04933292
- Testing
- Methylprednisolone and Mycophenolate mofetil, Methylprednisolone and azathioprine
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Xiaoli Fan
Decompensated Liver Cirrhosis, Primary Biliary Cholangitis
LEOPARD Training and Validation Data Collection Study
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 TVDCS (NCT06675604)
- Where
- 53 sites in Austria, Belgium and 5 more
- Volunteers
- 4,500 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Primary Biliary Cholangitis
Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA).
- Trial name
- IDEAL (NCT06060665)
- Testing
- Seladelpar 10 mg
- Where
- 45 sites in United States, Canada
- Volunteers
- 96 people
- Sponsor
- Gilead Sciences
Pruritus
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)
The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis.
- Trial name
- NCT05448170
- Testing
- Linerixibat
- Sponsor
- GlaxoSmithKline
Primary Biliary Cholangitis
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT05749822
- Testing
- Fenofibrate 200mg, UDCA
- Where
- 12 sites in China
- Volunteers
- 104 people
- Sponsor
- Xijing Hospital of Digestive Diseases