Clinical trials: Primary Biliary Cholangitis
Primary Sclerosing Cholangitis
Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world.
- Trial name
- CATCH-IT (NCT05462093)
- Testing
- Liver Multiscan sequences, Liver Multiscan analysis, MRCP+
- Volunteers
- 200 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
Primary Biliary Cirrhosis
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
The study is designed to evaluate the safety and efficacy of intravenous administration of bone marrow derived mesenchymal stem cells for patients with refractory primary biliary cirrhosis (PBC).
- Trial name
- MSCsTreatPBC (NCT01440309)
- Testing
- Biological: mesenchymal stem cell, ursodeoxycholic acid
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Robert Chunhua Zhao, MD, PhD
Cholestasis
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT02966834
- Testing
- GSK2330672
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 147 people
- Sponsor
- GlaxoSmithKline
Primary Biliary Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
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
Primary Sclerosing Cholangitis, Cholestasis
Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy
The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic…
- Trial name
- BEZASCLER (NCT04309773)
- Testing
- Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy
- Where
- France
- Volunteers
- 104 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Liver Cirrhosis, Hepatocellular Carcinoma (HCC)
A Simple Breath Test to Detect Liver Cancer and Monitor Liver Conditions
Liver cancer is often diagnosed too late for effective treatment. The VOCAL2 study is developing a simple, non-invasive breath test to help detect liver cancer earlier and monitor liver conditions like cirrhosis.
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma (HCC), Cholangiocarcinoma, Cholangitis, Sclerosing
- Trial name
- VOCAL2 (NCT06864195)
- Where
- United Kingdom
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Primary Sclerosing Cholangitis
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.
- Trial name
- NCT02247934
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Primary Biliary Cirrhosis
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations.
- Trial name
- NCT02823353
- Testing
- Fenofibrate, UDCA
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Xijing Hospital of Digestive Diseases
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
PBC
Study on Clinical and Pathological Features of Primary Biliary Cholangitis and Risk Factors Related to Disease Progression
Primary biliary cholangitis (PBC) is a chronic autoimmune intrahepatic cholestatic liver disease characterized by progressive, non-suppurative, destructive cholangitis, potentially leading to fibrosis, cirrhosis, and liver…
- Trial name
- NCT07733882
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Beijing Municipal Administration of Hospitals
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen
Primary Sclerosing Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT02943460
- Testing
- Cilofexor
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
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
Inflammatory Bowel Diseases, Primary Sclerosing Cholangitis
NKT Role in the Regulation of the Inflammatory Bowel Disease
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000).
- Trial name
- NKT-CSP/MICI (NCT02884557)
- Testing
- collection of gut biopsies collection of blood samples
- Where
- France
- Volunteers
- 64 people
- Sponsor
- University Hospital, Lille
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
Cholangitis, Sclerosing
Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
OBJECTIVES: I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
- Trial name
- NCT00004762
- Testing
- cladribine
- Volunteers
- 5 people
- Sponsor
- National Center for Research Resources (NCRR)
Primary Sclerosing Cholangitis, PSC
Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients
The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.
- Conditions
- Primary Sclerosing Cholangitis, PSC, Cholangiocarcinoma
- Trial name
- NCT04753996
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic