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Cholangitis, Sclerosing clinical trials

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NCT ID: NCT04309773 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

BEZASCLER
Start date: April 6, 2021
Phase: Phase 3
Study type: Interventional

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 acid therapy

NCT ID: NCT04181138 Recruiting - Liver Diseases Clinical Trials

Primary Sclerosing Cholangitis in Children

Start date: December 30, 2021
Phase:
Study type: Observational

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 identify factors that may cause the disease to progress more quickly. - Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning - Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.

NCT ID: NCT04133792 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

PiSCATIN
Start date: October 1, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices. Subjects will be randomized (1:1) between Simvastatin and placebo.

NCT ID: NCT04060147 Terminated - Clinical trials for Primary Sclerosing Cholangitis

Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

Start date: October 17, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of escalating doses of cilofexor (CILO) in participants with primary sclerosing cholangitis (PSC) and compensated cirrhosis.

NCT ID: NCT04024813 Completed - Clinical trials for Primary Sclerosing Cholangitis

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

Start date: November 12, 2019
Phase: Phase 2
Study type: Interventional

The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).

NCT ID: NCT04015310 Withdrawn - Clinical trials for Primary Sclerosing Cholangitis

Quantitative Magnetic Resonance Imaging in Biliary Disease: Health Economics Study

BISECT
Start date: December 21, 2020
Phase:
Study type: Observational

This is a health economic study on using quantitative magnetic resonance imaging in biliary disease. It is an observational study aiming to recruit 40 patients with Primary Sclerosing Cholangitis (PSC) in 12 months. The aim of the study is to assess the effect of result of enhanced Magnetic Resonance Cholangiopancreatography (MRCP+) on the physicians' diagnosis and/or plans for patients with suspected or confirmed PSC, compared with usual standard of care. This study also aims to identify the cost-effectiveness of adding MRCP+ to the standard care pathway.

NCT ID: NCT04006886 Completed - Clinical trials for Reduction of Intestinal Inflammatory Activity

Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)

PSt-GFD
Start date: July 11, 2017
Phase: N/A
Study type: Interventional

Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation. Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves). Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver. Proof of hypothesis: - Pilot study with n=20 patients with PSC - Explorative, open-label, mono-centric study - Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

NCT ID: NCT03951324 Enrolling by invitation - Cholangiocarcinoma Clinical Trials

Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

VLE-IOV
Start date: May 10, 2019
Phase:
Study type: Observational

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria. This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

NCT ID: NCT03890120 Terminated - Clinical trials for Primary Sclerosing Cholangitis

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

PRIMIS
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

NCT ID: NCT03872921 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

norUrsodeoxycholic Acid vs Placebo in PSC

Start date: February 8, 2018
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.