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Primary Biliary Cirrhosis clinical trials

View clinical trials related to Primary Biliary Cirrhosis.

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NCT ID: NCT05374200 Completed - Clinical trials for Primary Biliary Cirrhosis

Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)

Start date: October 3, 2021
Phase: N/A
Study type: Interventional

The investigators have designed a guided, online, multicomponent, mind-body intervention for participants with primary biliary cholangitis. The ability of the online intervention to impact the primary and secondary outcome measures will be assessed as compared to control.

NCT ID: NCT04791527 Completed - Clinical trials for Primary Biliary Cirrhosis

Online Wellness Intervention for Primary Biliary Cholangitis (PBC)

Start date: February 14, 2021
Phase: N/A
Study type: Interventional

Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. Patients and the Canadian PBC Society have identified the need for self-care tools to manage symptom burden. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD), the researchers have developed a mind-body wellness module specific for patients with PBC. The 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. In a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. At the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants one month after the program ends to asses their continued satisfaction with and adherence to the program.

NCT ID: NCT04604652 Completed - Clinical trials for Primary Biliary Cirrhosis

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

PRONTO-PBC
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy. Inadequate response is defined as persistently elevated serum alkaline phosphatase at greater than or equal to1.5 times the upper limits of normal for the testing lab in spite of having been on adequate doses of standard therapy with UDCA (ursodeoxycholic acid) at 13-15 mg/kg for at least 6 months.

NCT ID: NCT03941184 Completed - Clinical trials for Rheumatoid Arthritis

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Start date: January 1, 1995
Phase:
Study type: Observational

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

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: NCT03665519 Completed - Clinical trials for Primary Biliary Cirrhosis

Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis

NCT ID: NCT03590886 Completed - Clinical trials for Primary Biliary Cirrhosis

Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

Start date: August 22, 2018
Phase:
Study type: Observational [Patient Registry]

To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

NCT ID: NCT03489889 Completed - Clinical trials for Primary Biliary Cirrhosis

Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine

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

A manipulation and an integral part of the pharmaceutical practice, where, in addition to the supply of medicines and personalized products, they represent an alternative to the therapeutic schemes, manipulating drugs of almost all of them as therapeutic categories. One of the products and ursodeoxycholic acid, commercially known as Ursacol, a bile acid physiologically present in human bile, approved by Agência Nacional de Vigilância Sanitária (ANVISA), among several indications, for the treatment of the symptomatic form of primary biliary cholangitis, autoimmune etiology and predominant incidence in female. This is a prospective, cross-over, interventional and open-label study, where patients attending the inclusion and exclusion criteria are attended by the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHC-FMUSP) Pharmacy Division in the Pharmaceutical Care sector. As patient information as well as the prescribed drugs, compiled by a data collection instrument from the ICHC-FMUSP Pharmacy Division and a semi-structured questionnaire.

NCT ID: NCT03253276 Completed - Clinical trials for Primary Biliary Cirrhosis

Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT

Start date: May 19, 2016
Phase: Early Phase 1
Study type: Interventional

This is an investigator-initiated, double-blind crossover study on the mechanism of OCA treatment of patients with PBC. Hypothesis and significance The investigators will test the hypothesis that OCA administration to patients with PBC increases hepatobiliary secretion of cholylsarcosine assessed by PET/CT using 11C-labeled cholylsarcosine (11C-CSar) as tracer. The results of this research project will elucidate the mechanism of the effect of using OCA therapeutically in patients with PBC.

NCT ID: NCT03226067 Completed - Clinical trials for Primary Biliary Cirrhosis

Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

Start date: June 26, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).