Clinical trials: Biliary Cirrhosis, Primary
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
Ursodeoxycholic Acid, Primary Biliary Cirrhosis
Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine
A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost…
- Trial name
- NCT03489889
- Testing
- Ursodeoxycholic Acid 300mg tablet, Ursodeoxycholic Acid 300mg capsule
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- University of Sao Paulo General Hospital
Primary Biliary Cholangitis
Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis
To assess the efficacy of mindfulness-based intervention (MBI) intervention in the treatment of moderate or severe fatigue in patients with primary biliary cholangitis (PBC).
- Trial name
- NCT03684187
- Testing
- Mindfulness Based Intervention
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Yale University
Primary Biliary Cholangitis (PBC)
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)
A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).
- Trial name
- NCT05896124
- Testing
- 2mg CS0159
- Where
- 16 sites in China
- Volunteers
- 75 people
- Sponsor
- Cascade Pharmaceuticals, Inc
SCAD, Addison Disease
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity
This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.
- Conditions
- SCAD, Addison Disease, Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome
- Trial name
- NCT03941184
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Mayo Clinic
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc
Autoimmune Hepatitis, Primary Sclerosing Cholangitis
Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome
In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.
- Conditions
- Autoimmune Hepatitis, Primary Sclerosing Cholangitis, Non-Alcoholic Fatty Liver Disease, Liver Abscess
- Trial name
- LGAS (NCT06519162)
- Where
- South Korea
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Chungnam National University Hospital
Primary Biliary Cirrhosis
Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis
Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often require liver transplantation. The cause of disease is unknown.
- Trial name
- HAART (NCT01614405)
- Testing
- TDF/FTC/LPV/r
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- University of Alberta
Primary Biliary Cholangitis, Cardiovascular Abnormalities
Early Identification of Myocardial Impairment in PBC
Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands.
- Trial name
- EARLY-MYO-PBC (NCT03545672)
- Testing
- CMR examination
- Where
- China
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- RenJi Hospital
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104.
- Trial name
- NCT05104853
- Testing
- CNP-104
- Where
- 19 sites in United States
- Volunteers
- 42 people
- Sponsor
- COUR Pharmaceutical Development Company, Inc.
Primary Biliary Cholangitis, Liver Stiffness
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
The primary objective of this study is to evaluate the effect of setanaxib on alkaline phosphatase (ALP) at Week 24 in participants with PBC and with elevated liver stiffness and intolerance or inadequate response to…
- Trial name
- TRANSFORM (NCT05014672)
- Testing
- Setanaxib
- Where
- 128 sites in United States, Australia and 16 more
- Volunteers
- 76 people
- Sponsor
- Calliditas Therapeutics Suisse SA
PBC, Primary Biliary Cholangitis (PBC)
Epidemiology of PrImary Biliary Cholangitis in Spain
Primary biliary cholangitis (PBC) is a rare, long-term liver disease that can slowly damage the bile ducts, eventually leading to cirrhosis and, in some cases, the need for a liver transplant.
- Trial name
- EPIC-PBC (NCT07821463)
- Where
- Spain
- Volunteers
- 3,000 people
- Sponsor
- Fundacio Privada Mon Clinic Barcelona
Hepatitis, Autoimmune, Cholangitis
Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents
- Conditions
- Hepatitis, Autoimmune, Cholangitis, Liver Cirrhosis, Biliary, Cholestasis
- Trial name
- NCT02936596
- Testing
- Ursodeoxycholic acid combination of immunosuppressive agents, Ursodeoxycholic Acid
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Xiaoli Fan
Primary Biliary Cholangitis, Intrahepatic Bile Duct Cancer
Patients With Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a chronic autoimmune disease characterized by progressive destruction of the small intrahepatic bile ducts, leading to cholestasis and potential progression to cirrhosis.
- Conditions
- Primary Biliary Cholangitis, Intrahepatic Bile Duct Cancer, Cancer Liver
- Trial name
- BILIFLEX (NCT07573514)
- Testing
- Reflex AMA and ANA testing
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Biliary Cirrhosis, Primary
IBAT Inhibitor A4250 for Cholestatic Pruritus
This study will evaluate the safety, tolerability and influence on itching, bile acids and liver enzyme changes in patients with PBC (Primary Biliary Cirrhosis) treated with A4250
- Trial name
- NCT02360852
- Testing
- A4250
- Where
- Sweden
- Volunteers
- 9 people
- Sponsor
- Sahlgrenska University Hospital
Primary Bilary Cirrhosis (PBC)
Clinical Characterization of Patients With Primary Biliary Cirrhosis Treated With Seladelpar in the Real-life Setting
The seladelpar registry will collect real-world data of patients with PBC diagnosis treated with seladelpar in the real-life scenario in Germany and Switzerland.
- Trial name
- SENSE registry (NCT07549607)
- Where
- 21 sites in Germany, Switzerland
- Volunteers
- 100 people
- Sponsor
- University of Leipzig
Primary Biliary Cholangitis
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
The purpose of this study is to find out about the safety and how well the study intervention (elafibranor) works in participants with PBC.
- Trial name
- ELONSEN (NCT06730061)
- Testing
- Elafibranor
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Ipsen
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
- Conditions
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis, Cholestasis
- Trial name
- NCT07843420
- Testing
- Nemolizumab-ilto
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Cholestasis
Linerixibat Long-term Safety, and Tolerability Study
This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who…
- Trial name
- LLSAT (NCT04167358)
- Testing
- Linerixibat
- Where
- 94 sites in United States, Argentina and 15 more
- Volunteers
- 242 people
- Sponsor
- GlaxoSmithKline