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Cholangitis, Sclerosing clinical trials

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NCT ID: NCT02446665 Active, not recruiting - Clinical trials for Magnetic Resonance Imaging

Disease Status in Primary Sclerosing Cholangitis by Elastography

Start date: October 2014
Phase: N/A
Study type: Interventional

Primary sclerosing cholangitis (PSC) is a chronic liver disease that can lead to liver cirrhosis, liver failure and liver cancer. Assessment of disease status is important to determine optimal treatment but the diagnosis of PSC is challenging. There is a dire need of an accurate non-invasive tool for longitudinal assessment of PSC. MR Elastography (MRE) has been recently proven to estimate liver fibrosis noninvasively and accurately. Estimation of liver fibrosis by MRE along with imaging derived morphological information (MRCP) will be utilized in this study comprehensively to provide a surrogate non-invasive imaging biomarker for monitoring disease status in PSC. Successful outcomes will provide an opportunity for optimal treatment triage including liver transplantation via accurate and non-invasive estimation of true disease status in PSC.

NCT ID: NCT02424175 Completed - Clinical trials for Sclerosing Cholangitis

Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Start date: February 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2 who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use

NCT ID: NCT02247934 Completed - Clinical trials for Primary Sclerosing Cholangitis

Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)

Start date: October 2014
Phase: N/A
Study type: Observational

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.

NCT ID: NCT02247622 Recruiting - Clinical trials for Inflammatory Bowel Disease

Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis

Start date: February 2012
Phase: N/A
Study type: Observational

PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.

NCT ID: NCT02239211 Completed - Clinical trials for Primary Sclerosing Cholangitis

A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis

BUTEO
Start date: September 8, 2015
Phase: Phase 2
Study type: Interventional

This is a phase II study to determine the safety and preliminary efficacy of a human monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use in the treatment of patients with primary sclerosing cholangitis (PSC).

NCT ID: NCT02177136 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

AESOP
Start date: February 9, 2015
Phase: Phase 2
Study type: Interventional

This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to evaluate the safety, tolerability, and efficacy of long-term, open-label use of OCA in participants with PSC who had completed the DB phase of the study.

NCT ID: NCT02137668 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.

NCT ID: NCT02061540 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis

CAMEO
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The study is an open-label study in adults with primary sclerosing cholangitis to evaluate the safety, tolerability, and effect of 14-weeks of daily dosing of LUM001.

NCT ID: NCT01988506 Completed - Clinical trials for Rheumatoid Arthritis

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

TRANSREG
Start date: January 6, 2014
Phase: Phase 2
Study type: Interventional

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

NCT ID: NCT01880606 Completed - Clinical trials for Inflammatory Bowel Disease

Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance

pCLE-PSC-IBD
Start date: August 2011
Phase: N/A
Study type: Observational [Patient Registry]

Evaluation of the efficacy of laser-based endomicroscopy as a complement to white-light colonoscopy and chromoendoscopy for early detection of colon dysplasia in patients with PSC-IBD. White-light colonoscopy is a routinely used procedure in colorectal cancer surveillance programs. However, it does not permit detection of early dysplastic lesions. Chromoendoscopy by applying a dye (indigo-carmine) through the colonoscope helps to identify flat lesions but is not suitable for accurate endoscopic diagnosis of dysplasia and intraepithelial neoplasia Under this aim we will perform a clinical study evaluating a newly developed technique allowing for in vivo confocal microscopy assessment of the colon mucosa using laser-based endomicroscopy together with intravenous administration of fluorescein (FITC).