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Cholangitis clinical trials

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NCT ID: NCT05896137 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

Start date: August 7, 2023
Phase: Phase 2
Study type: Interventional

A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis)

NCT ID: NCT05896124 Recruiting - Clinical trials for Primary Biliary Cholangitis (PBC)

CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

Start date: August 7, 2023
Phase: Phase 2
Study type: Interventional

A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).

NCT ID: NCT05876182 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Vancomycin in Primary Sclerosing Cholangitis in Italy

VanC-IT
Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.

NCT ID: NCT05835505 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

Detoxification of the Liver In PSC (Dolphin)

DOLPHIN
Start date: December 12, 2023
Phase: Phase 2
Study type: Interventional

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with primary sclerosing cholangitis. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.

NCT ID: NCT05832229 Recruiting - Cirrhosis Clinical Trials

Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States

LCN RESCU
Start date: October 11, 2023
Phase: Phase 2
Study type: Interventional

This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.

NCT ID: NCT05800171 Recruiting - Cholangitis Clinical Trials

Efficacy of Single Use Disposable Elevator Cap (DEC) Duodenoscopy

Start date: April 24, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this prospective cohort observational study is to compare incidence of cholangitis cause by multi-drug resistant pathogens in patient who underwent ERCP. The main question it aims to answer are: - Is the single use disposable elevator cap duodenoscope more effective in preventing cholangitis caused by MDR than fixed cap duodeoscope? - Is the single use disposable elevator cap duodenoscope more effective in preventing severe cholangitis than fixed cap duodenoscope? Participants will undergo and ERCP procedure. Among the patients who received the procedure, those who developed cholangitis after procedure will treated with antibiotics after blood culture test. The result of the post procedure cholangitis group's blood culture test and lab data including LFT will be collected. Researches will compare single use disposable elevator cap duodenoscope group and fixed distal cap duodenoscope group to see if there is difference in the incidence of cholangitis caused by MDR pathogens.

NCT ID: NCT05786482 Recruiting - Cancer Clinical Trials

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

EMPOwer
Start date: February 12, 2023
Phase: N/A
Study type: Interventional

Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. 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 eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

NCT ID: NCT05751967 Recruiting - Clinical trials for Primary Biliary Cholangitis

Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis

Start date: February 22, 2023
Phase: Phase 3
Study type: Interventional

Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.

NCT ID: NCT05750966 Recruiting - Cholangitis Clinical Trials

Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis

COBRA
Start date: July 19, 2023
Phase: N/A
Study type: Interventional

The goal of this multicentre randomized controlled trial is to investigate if a very short-course of antibiotics (1 day) for cholangitis after adequate drainage is non-inferior with respect to clinical cure in comparison with a standard course of antibiotics (4 to 7 days). Secondary objectives include: - Will a one-day course of antibiotics for cholangitis after adequate drainage be non-inferior with respect to relapse of cholangitis and mortality in comparison with a standard course of antibiotics? - Will a one-day course of antibiotics for cholangitis after adequate drainage result in less adverse drug events in comparison with a standard course of antibiotics? - Will a one-day course of antibiotics for cholangitis after adequate drainage reduce length of hospital stay? - Will a one-day course of antibiotics for cholangitis after adequate drainage improve quality of life? - Will a one-day course of antibiotics for cholangitis after adequate drainage be cost-effective?

NCT ID: NCT05750498 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

ALINK
Start date: April 28, 2022
Phase:
Study type: Observational [Patient Registry]

The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD). This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative. Pediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease. The aims of A-LiNK are to: 1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.