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Cholangitis, Sclerosing clinical trials

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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

NCT ID: NCT02712736 Completed - Clinical trials for Primary Sclerosing Cholangitis

Quality of Life in Patients With Primary Sclerosing Cholangitis

QOL in PSC
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and alternative medicine use in patients with PSC.

NCT ID: NCT02705638 Completed - Clinical trials for IgG4-related Disease

Treatment of IgG4-Related Disease With Revlimid and Rituximab

TIGR2
Start date: April 2016
Phase: Phase 1
Study type: Interventional

Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?

NCT ID: NCT02704364 Completed - Clinical trials for Primary Sclerosing Cholangitis

Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

NCT ID: NCT02701166 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

The Effect of Bezafibrate on Cholestatic Itch

FITCH
Start date: February 2016
Phase: Phase 3
Study type: Interventional

Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

NCT ID: NCT02653625 Completed - Clinical trials for Primary Sclerosing Cholangitis

PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

Start date: March 14, 2016
Phase: Phase 2
Study type: Interventional

This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.

NCT ID: NCT02616705 Completed - Clinical trials for IgG4-related Disease

Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Start date: November 2015
Phase:
Study type: Observational

Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

NCT ID: NCT02605213 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients

Start date: September 2015
Phase: Phase 4
Study type: Interventional

Primary sclerotic cholangitis (PSC) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. There is no curative treatment for this disorder. Supportive and conservative treatments are the most common therapies that used for this disease. Although treatments such as ursodeoxycholic acid (UDCA) are recommended in some situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria such as cholestridium difficile as pathogenesıs of PSC, so use of antibiotics is recommended for treatment of these patients. Therefore according to the great role of anaerobic bacteria such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and vancomycin can be counted as recommended therapies in PSC. In addition some studies correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of inflammation in biliary system. But with all this detail there is no finality about effectiveness of antibiotic therapy and accordingly in this study the investigators compare oral vancomycin effect versus placebo in primary sclerosing cholangitis patients. In this double blind clinical trial 30 primary sclerosing cholangitis patients that divided in two 15 persosns group with Block Randomization method. in this study one group receive 250 mg oral vancomycin every 6 hours and other group receive placebo. The study duration is 12 weeks . The baseline laboratory tests and 1 month and 3 months after treatment concept of; Alkaline phosphatase, ALT, AST, GGT and serum total bilirubin and clinical manifestations such as tiredness, itching and probable adverse effects such as hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.

NCT ID: NCT02545309 Active, not recruiting - Clinical trials for Secondary Sclerosing Cholangitis

Secondary Sclerosing Cholangitis in Critically Ill Patients

SSC-CIP
Start date: December 21, 2015
Phase:
Study type: Observational

SSC-CIP is increasing in patients after critical illness. Pathogenesis is still largely unclear. The investigators hypothesize that genetic variants of biliary transporter genes are frequent in patients with SSC-CIP. In approximately 140 patients and controls the rate of genetic variants in biliary transporter genes, gut permeability and gut microbiome as well as bone health will be studied.

NCT ID: NCT02464020 Completed - Clinical trials for Inflammatory Bowel Disease

A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis

Start date: July 2015
Phase: Phase 1
Study type: Interventional

The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. The investigators will also assess the blood and stool of healthy people, and people with IBD (without PSC) as a control group.