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Cholangitis clinical trials

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NCT ID: NCT05925309 Recruiting - Biliary Atresia Clinical Trials

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.

NCT ID: NCT05920954 Recruiting - Acute Cholangitis Clinical Trials

Urgent (<24 Hours) Versus Early (24 to 48 Hours) ERCP for Patients With Mild and Moderate Acute Cholangitis

Start date: June 30, 2023
Phase: N/A
Study type: Interventional

Acute Cholangitis is an emergency associated with significant morbidity and mortality which require prompt recognition and treatment. The decompression of biliary tree along with antibiotics are mainstay of therapy. Randomized comparative studies showed that ERCP achieves biliary decompression with markedly less morbidity and mortality compared with surgery, regardless of clinical drainage. Percutaneous trans hepatic drainage (PTBD) can be alternative to endoscopic drainage in selected group especially advanced hilar strictures and patients who are unfit for endoscopic procedure. Recent ASGE guidelines suggested the performance of ERCP within 48 hours for patients with acute cholangitis; however it is conditional recommendation with very low quality of evidence. Till date, no randomized trial has compared urgent ERCP versus early ERCP for acute cholangitis.

NCT ID: NCT05919433 Recruiting - Clinical trials for Primary Biliary Cholangitis

Detection Program for Patients With Primary Biliary Cholangitis Lost in the System

RESCAT
Start date: May 1, 2023
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance. According to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer >1:40) and/or anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and/or anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis). The incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively. The objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.

NCT ID: NCT05912387 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

Start date: May 31, 2023
Phase: Early Phase 1
Study type: Interventional

PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection. Additionally, many patients require a liver transplant. Progress towards a cure has been severely limited by an incomplete understanding of why patients develop PSC. The investigators aim to close this gap by conducting a pilot human study in patients with PSC, using statin therapy as a model

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: 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: 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.