S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis (PSC)The aim of this study is to investigate clinical effects (liver biochemistries, health-related quality of life, liver stiffness) and underlying mechanisms of hepatoprotection of S-adenosylmethionine in patients with primary sclerosing cholangitis. The study will be performed in a randomized and placebo-controlled fashion.
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Primary Sclerosing CholangitisPrimary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC). Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care. To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.
Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH
CholangitisSclerosing2 moreMERLIN is an adaptive, single arm, multi-centre, phase IIa multi-disease clinical trial. It is designed to: i) Determine dose safety of ORBCEL-C™ (selected Mesenchymal stromal cells derived from human umbilical cord) ii) Evaluate treatment activity through assessment of biomarkers (for patients treated at the highest safe dose only (HSD)) This trial will determine the Highest Safe Dose (HSD) that can be administered by observing for occurrence of dose limiting toxicity (DLT). Upon completion of this trial we hope to be able to justify and conduct separate, larger scale trials using ORBCEL-C™.
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing CholangitisThis is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices. Subjects will be randomized (1:1) between Simvastatin and placebo.
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Primary Sclerosing CholangitisBiliary AtresiaThe purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.
CM-101 in PSC Patients -The SPRING Study
Primary Sclerosing CholangitisThis study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
CirrhosisCirrhosis11 moreThis 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.
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing...
Primary Sclerosing CholangitisThis study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.
Vancomycin in Primary Sclerosing Cholangitis in Italy
Primary Sclerosing CholangitisLiver and Intrahepatic Bile Duct Disorder1 morePrimary 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.
Gluten-free Diet in PSC and IBD
Primary Sclerosing CholangitisUlcerative Colitis3 morePrimary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study. Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.