View clinical trials related to Cholangitis.
Filter by:Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease. Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment). The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease. There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored. Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio). Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver). They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months).
1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.
This study aims to use positron emission tomography (PET)/magnetic resonance imaging (MRI) to diagnose and quantify PSC-related biliary tract fibrosis and to improve upon the currently available non-invasive diagnostic capabilities by investigating the ability of combined PET/MRI to detect and quantify fibrosis using a novel collagen-binding radiotracer. Specifically, the investigators will be comparing [68Ga]CBP8- and [18F]-FAPI-74 PET/MRI to a liver transient elastography scan in the diagnosis of biliary tree fibrosis.
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
This is an Investigator Initiated, single center, non-randomized, single arm study utilizing TruGraf liver gene expression serial testing in patients with autoimmune liver diseases (AIH, PSC, PBC) monthly for the first 6 months after transplant to help inform immunosuppression (IS) optimization. Approximately 20 patients will be enrolled in the study. Study outcomes will include 1-year graft survival, 1 year BPAR and clinically treated rejection rates, number of changes to IS based on the results of Trugraf, eGFR and immune mediated issues. TruGraf®, (Transplant Genomics, Inc., a member of Eurofins Transplant Diagnostics) is a non-invasive blood-based test to assist the clinician in lowering immunosuppression in liver transplant patients. It is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Unfortunately, achieving the tight control of therapeutic levels of immunosuppression that is required to maintain the balance between "too much" and "too little" can be difficult. TruGraf liver can help clinicians confirm immune "quiescence" prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection. The clinical context of use for TruGraf is to provide reassurance to the clinician who is contemplating a preemptive reduction in IS therapy that a patient's immune status is "quiescent" thus reducing the risk of triggering acute rejection with that IS reduction. Having the ability to assess whether the patient's immune status is "quiescent" or activated when considering an increase or decrease in IS therapy allows the clinician greater confidence in decision making.
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years. Diagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy. Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. Also, the lack of surrogate endpoints impedes performing clinical research. Recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by MRC. These tools called MRCP+ (quantitative magnetic resonance cholangiopancreatography +) and LiverMultiscan (LMS) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, several features must be tested before the utility of this tools in clinical patient care can be concluded. Therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual MRI's.
Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease. Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients. Novel imaging techniques called MRCP+ and Liver Multiscan (LMS) hold the prospect of adequate depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, these features must be tested first. The purpose of this study is to assess the (i) ability of MRCP+ to detect change in biliary volume, (ii) reproducibility of MRCP+ and LMS, and (iii) correlation of MRCP+ with ERC findings as gold standard.