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Cholangitis, Sclerosing clinical trials

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NCT ID: NCT06037577 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.

NCT ID: NCT05866809 Completed - Clinical trials for Primary Sclerosing Cholangitis

Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis

Start date: October 28, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC). Percentage of subjects who show improvement of severity of PSC as assessed by Magnetic Resonance Cholangiopancreatography(MRCP) at Week 12 from baseline, with improvement defined as a decrease of -1 or more in the MRCP and change of alkaline phosphatase(ALP) level will be assessed at Week 12 from baseline.

NCT ID: NCT05233553 Completed - COVID-19 Clinical Trials

SSC-COVID in Patients After COVID-19

Start date: March 1, 2020
Phase:
Study type: Observational

Analysis of occurrence of SSC-COVID in SARS-CoV-2-patients after the first wave of COVID-pandemic

NCT ID: NCT05082779 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159

Start date: October 26, 2021
Phase: Phase 1
Study type: Interventional

The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part also involves a pilot food effect (FE) study, designed to assess the food effect on single-dose PK profile in healthy subjects.

NCT ID: NCT04480840 Completed - Clinical trials for Primary Sclerosing Cholangitis

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

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: 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: NCT03809559 Completed - Liver Diseases Clinical Trials

Repeatability and Reproducibility of Quantitative MRCP

Start date: July 19, 2018
Phase:
Study type: Observational

This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP). Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This enables advanced quantitative measurement of bile duct width, orientation, branching point and curvative metrics. The technology has been validated against 3D printed phantoms for accuracy, and early clinical research has demonstrated the technology has potential for clinical impact, with improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal et al 2017). Quantitative MRCP aims to act as a tool to not only improve assessment of the current status of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it must be established that any change between scans is due to change in the physiology of the individual and not due to a quirk or fault of the technology. In order to achieve this a series of scans will be performed on an individual over a short period of time, for which the condition of the biliary tree within that individual can be assumed to be constant. Between each scan, subject and coil repositioning will occur. The study will recruit a group of adult volunteers, from both diseased groups and healthy groups in order to achieve a range of physiological biliary metrics.

NCT ID: NCT03766035 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Start date: December 6, 2018
Phase:
Study type: Observational

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

NCT ID: NCT03722576 Completed - Clinical trials for Primary Sclerosing Cholangitis

Vidofludimus Calcium for Primary Sclerosing Cholangitis

PSC
Start date: June 17, 2019
Phase: Phase 2
Study type: Interventional

To examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period.