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Primary Sclerosing Cholangitis clinical trials

View clinical trials related to Primary Sclerosing Cholangitis.

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NCT ID: NCT03175471 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

Start date: January 17, 2017
Phase:
Study type: Observational

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 elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.

NCT ID: NCT03099603 Completed - Clinical trials for Primary Sclerosing Cholangitis

A Study of HTD1801 in Healthy Subjects

Start date: March 24, 2017
Phase: Phase 1
Study type: Interventional

This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.

NCT ID: NCT03069976 Completed - Clinical trials for Primary Sclerosing Cholangitis

"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"

Start date: January 2016
Phase: N/A
Study type: Interventional

Based upon the possible implication of microbiota and abnormal microbial metabolites such as altered bile acids, in the pathogenesis of PSC, emerging data suggests that oral antibiotics, such as vancomycin and metronidazole, may have therapeutic effects in this overlap syndrome or PSC. The goal of our study is to evaluate role of antibiotics and microflora in children with AIH/PSC overlap syndrome or with PSC alone. The investigators hope to learn what effects oral antibiotics has on the bacteria present in stool, and hope to learn to characterize human intestinal microbial communities, in children suffering from overlap syndrome or PSC. The hypothesis of the investigators is that overlap syndrome and PSC develop due to altered microflora and the resulting abnormal bile acids pool. The outcome of overlap syndrome or PSC could be affected by presence or absence of RCUH. Antibiotics to correct the microflora may result in disease/cholangiopathy remission.

NCT ID: NCT03046901 Withdrawn - Clinical trials for Primary Sclerosing Cholangitis

Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Start date: December 7, 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the safety and efficacy of oral vancomycin in patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The primary endpoint is looking at the effect of the drug on liver function tests, an important surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a decrease in liver function tests at 1 year, changes in bilirubin and adverse events. Effective treatment at the onset of PSC recurrence may lead to decreases in disease progression, recurrent liver failure, and repeat liver transplantation.

NCT ID: NCT03041662 Completed - Cholangiocarcinoma Clinical Trials

Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)

PSC
Start date: October 31, 2011
Phase:
Study type: Observational

This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.

NCT ID: NCT03035058 Withdrawn - Clinical trials for Inflammatory Bowel Disease

Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease

Start date: February 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD).

NCT ID: NCT02978339 Completed - Clinical trials for Primary Sclerosing Cholangitis

A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)

Start date: June 9, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether curcumin, a drug and naturally-occurring plant compound, is safe and effective in the treatment of primary sclerosing cholangitis (PSC).

NCT ID: NCT02943460 Completed - Clinical trials for Primary Sclerosing Cholangitis

Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis

Start date: November 29, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (PSC).

NCT ID: NCT02884557 Completed - Clinical trials for Inflammatory Bowel Diseases

NKT Role in the Regulation of the Inflammatory Bowel Disease

NKT-CSP/MICI
Start date: May 2013
Phase: N/A
Study type: Interventional

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). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation. Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.

NCT ID: NCT02736708 Completed - Clinical trials for Primary Sclerosing Cholangitis

Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures

PSCRegistry
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

Primary sclerosing cholangitis (PSC) 1. Prospectively validate interpretation criteria for the characterization of PSC strictures 2. Prospectively evaluate the accuracy of pCLE for the characterization of PSC strictures (differentiation between malignant vs. non malignant strictures), using the newly developed interpretation criteria 3. Evaluate the feasibility and safety of pCLE for the characterization of PSC strictures