A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT05627362
Recruiting
This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the stud... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
11/30/2023
Locations: Om Research LLC, Lancaster, California +61 locations
Conditions: Primary Sclerosing Cholangitis
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Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
NCT04685200
Recruiting
Background: Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease. Objective: To understand the biological causes of primary sclerosing cholangitis. Eligibility: Adults age 18 and older who have primary sclerosing cholangitis. Design: Participants will be screened with a medical history, physical exam, a... Read More
Gender:
All
Ages:
18 years and above
Trial Updated:
11/14/2023
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland
Conditions: Primary Sclerosing Cholangitis
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Primary Sclerosing Cholangitis in Children
NCT04181138
Recruiting
Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: Collect medical and other data to learn more about PSC, how it progresses, and... Read More
Gender:
All
Ages:
Between 2 years and 25 years
Trial Updated:
10/13/2023
Locations: Children's Hospital of Los Angeles, Los Angeles, California +11 locations
Conditions: Primary Sclerosing Cholangitis, Liver Diseases, Cholangitis, Sclerosing
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Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
NCT05295680
Recruiting
Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC). Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care. To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely:... Read More
Gender:
All
Ages:
Between 14 years and 75 years
Trial Updated:
10/04/2023
Locations: Stanford Clinic, Redwood City, California +1 locations
Conditions: Primary Sclerosing Cholangitis
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CM-101 in PSC Patients -The SPRING Study
NCT04595825
Recruiting
This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
09/13/2023
Locations: Scripps Clinic Torrey Pines - site P83, La Jolla, California +52 locations
Conditions: Primary Sclerosing Cholangitis
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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
NCT04663308
Recruiting
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.
Gender:
All
Ages:
16 years and above
Trial Updated:
09/05/2023
Locations: Southern California Research Center, Coronado, California +59 locations
Conditions: Primary Sclerosing Cholangitis
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Vancomycin for Primary Sclerosing Cholangitis
NCT03710122
Recruiting
To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD
Gender:
All
Ages:
Between 18 years and 76 years
Trial Updated:
09/01/2023
Locations: Mayo Clinic Arizona, Phoenix, Arizona +3 locations
Conditions: Primary Sclerosing Cholangitis
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Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
NCT05912387
Recruiting
PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection. Additionally, many patients require a liver transplant. Progress towards a cure has been severely limited by an incomplete understanding of why patients develop PSC. The investigators aim to close this gap by conducting a pilot human study in patients with PSC, using statin therapy as a model
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
06/12/2023
Locations: Stanford University, Stanford, California
Conditions: Primary Sclerosing Cholangitis, Inflammatory Bowel Diseases
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Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT
NCT03183570
Recruiting
Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT
Gender:
All
Ages:
18 years and above
Trial Updated:
05/27/2023
Locations: Stanford University, Stanford, California
Conditions: Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, Covid19 Pneumonia
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MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
NCT03175471
Recruiting
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastogr... Read More
Gender:
All
Ages:
Between 6 years and 23 years
Trial Updated:
03/01/2023
Locations: Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio
Conditions: Autoimmune Liver Disease, Primary Sclerosing Cholangitis, Autoimmune Hepatitis
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A-LiNK: Improving Outcomes in Autoimmune Liver Disease
NCT05750498
Recruiting
The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD). This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative. Pediatric Autoimmune Hepatitis (AIH) and Primary Scleros... Read More
Gender:
All
Ages:
All
Trial Updated:
02/28/2023
Locations: Stanford University, Palo Alto, California +4 locations
Conditions: Autoimmune Hepatitis, Primary Sclerosing Cholangitis
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MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
NCT03178630
Recruiting
Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection o... Read More
Gender:
All
Ages:
Between 6 years and 23 years
Trial Updated:
02/13/2023
Locations: Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio
Conditions: Autoimmune Liver Disease, Autoimmune Hepatitis, Primary Sclerosing Cholangitis
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