Cholangitis sclerosing – European Clinical Trials Information Network

Study of Fecal Microbiota Transplantation Compared to Sham Treatment for Patients with Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 15:08:30 +0000

This study is looking at Primary Sclerosing Cholangitis, a condition where the bile ducts inside and outside the liver become inflamed and scarred, which can lead to liver damage over time. The study involves patients who also have inflammatory bowel disease, which is a condition causing long-term inflammation of the digestive tract. Participants will already be receiving standard treatment with ursodeoxycholic acid, a medication that helps protect the liver. The study will test a treatment called fecal microbiota transplantation, which involves transferring stool material from healthy donors to the patient. This transplant can be given in different ways: through capsules taken by mouth, through an enema, or through a procedure using a colonoscope. Some participants will receive placebo instead of the actual fecal microbiota transplant.

The purpose of the study is to find out if fecal microbiota transplantation can improve certain blood test results that indicate how well the liver is functioning, specifically levels of alkaline phosphatase and bilirubin, which are substances that can build up when the liver or bile ducts are not working properly. The study will compare the results between patients who receive the actual fecal microbiota transplant and those who receive the placebo treatment.

During the study, patients will be monitored for 48 weeks with regular visits where blood tests will be done to check liver function. Additional tests will include measurements of liver stiffness, imaging of the bile ducts using magnetic resonance cholangiography, and colonoscopy to check the bowel condition. Patients will also complete questionnaires about symptoms like itching, fatigue, and quality of life. Stool samples will be collected to study changes in the gut bacteria. Some patients may continue to be followed for up to 104 weeks to assess longer-term effects.

Study on the Safety and Tolerability of Norucholic Acid Tablets for Patients with Primary Sclerosing Cholangitis (PSC)

Wed, 29 Apr 2026 15:03:07 +0000

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The study will use a treatment called norucholic acid, which is provided in the form of film-coated tablets. Norucholic acid is a synthetic version of a naturally occurring substance in the body known as bile acid.

The purpose of this study is to evaluate the safety and tolerability of norucholic acid in patients with PSC. Participants in the study will take norucholic acid tablets orally. The study will monitor participants over a period to observe any side effects or reactions to the treatment. The study will also look at changes in liver health and other safety measures, such as blood pressure and body weight.

Throughout the study, researchers will keep track of any adverse events, which are any unwanted effects that occur during the treatment. The study aims to ensure that norucholic acid is safe for use in treating PSC and to understand how it affects the liver and overall health of the participants. The study is open-label, meaning both the researchers and participants know what treatment is being administered.

Study on the Safety and Effectiveness of Elafibranor for Adults with Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 15:00:24 +0000

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the gallbladder and small intestine. The study is testing a treatment called elafibranor, which is taken as a film-coated tablet. Elafibranor works by activating certain proteins in the body that may help improve liver function. The study will compare the effects of elafibranor at two different doses, 80 mg and 120 mg, to a placebo, which is a tablet that does not contain any active medication.

The purpose of the study is to evaluate the safety and effectiveness of elafibranor in adults with PSC. Participants will take the medication daily for a period of 12 weeks during the initial phase of the study. After this period, there is an option for participants to continue in a long-term extension phase, where they can receive elafibranor for a longer duration to further assess its safety and tolerability. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition.

This study aims to provide valuable information about the potential benefits and risks of using elafibranor for treating PSC. By participating, individuals with PSC can contribute to research that may lead to better treatment options for this challenging liver disease. The study is conducted under strict guidelines to ensure the safety and well-being of all participants.

Study on Bezafibrate for Patients with Primary Sclerosing Cholangitis and Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

Wed, 29 Apr 2026 14:59:39 +0000

This clinical trial is focused on studying the effects of a medication called bezafibrate in patients with a liver disease known as Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts, which carry digestive fluid from the liver to the small intestine, become inflamed and scarred, leading to liver damage. The study is specifically looking at patients who continue to have a condition called cholestasis, which is a reduction or stoppage of bile flow, despite being treated with a standard medication called ursodeoxycholic acid (UDCA).

The purpose of the study is to evaluate the effectiveness of bezafibrate over a period of 24 months. Participants in the study will be randomly assigned to receive either bezafibrate or a placebo, in addition to their usual UDCA treatment. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving bezafibrate and who is receiving the placebo, to ensure unbiased results.

Throughout the study, participants will continue their regular medical care and will have periodic check-ups to monitor their health and the effects of the treatment. The study aims to see if bezafibrate can help improve liver function and reduce symptoms in patients with PSC. The trial will last for two years, and participants will be closely monitored for any changes in their condition and overall health.

Study on Simvastatin for Treating Primary Sclerosing Cholangitis in Patients

Wed, 29 Apr 2026 14:56:44 +0000

This clinical trial is focused on studying the effects of the medication Simvastatin on a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The study will use Simvastatin Sandoz 40 mg film-coated tablets as the treatment, and some participants will receive a placebo for comparison.

The purpose of the study is to determine if treatment with simvastatin can help prolong the time patients live without developing bile duct cancer, experiencing bleeding from enlarged veins in the esophagus (variceal bleeding), or needing a liver transplant. Participants in the study will be randomly assigned to receive either simvastatin or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study.

The study will take place over a period of time, during which participants will be monitored for various health outcomes. These include the number of days from the start of the study to events such as death, the need for a liver transplant, or the first occurrence of variceal bleeding. Additionally, the study will track changes in certain blood tests and symptoms related to PSC, such as itching or infections that require treatment. The study aims to provide valuable information on whether simvastatin can be an effective treatment for PSC.

Study on Low-Dose Aldesleukin for Patients with Pemphigus, Mucous Membrane Pemphigoid, Polymyositis, Dermatomyositis, and Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 14:30:30 +0000

This clinical trial is focused on studying the safety and effectiveness of a treatment for several chronic inflammatory diseases. The diseases being studied include Mucous Membrane Pemphigoid, Primary Sclerosing Cholangitis, Pemphigus Vulgaris, and Polymyositis/Dermatomyositis. The treatment being tested is a low-dose form of Interleukin-2, also known by its code name IL-2. This medication is administered as a solution for injection or infusion. The study will also use Glucose as part of the trial.

The purpose of this study is to evaluate the safety and the relationship between the body’s immune response and the clinical outcomes when using low-dose IL-2 therapy in patients with these diseases. Participants will receive the treatment over a period of eight weeks. The study is designed to be randomized, meaning participants will be randomly assigned to different groups, and double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or a placebo. This helps ensure the results are unbiased.

Throughout the study, researchers will monitor the participants’ immune responses and any changes in their disease symptoms. The goal is to understand how the treatment affects the immune system and whether it leads to improvements in the conditions being studied. The trial will help determine if low-dose IL-2 therapy is a safe and effective option for managing these chronic inflammatory diseases.

Study on Pyridoxine for Patients with Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 14:26:06 +0000

This clinical trial is focused on studying the effects of a treatment for Primary Sclerosing Cholangitis (PSC), a disease that affects the bile ducts in the liver. The treatment being tested is Pyridoxine Hydrochloride, which is also known as Vitamin B6. The study aims to determine if pyridoxine is more effective than a placebo in reducing levels of a liver enzyme called alkaline phosphatase, which is often elevated in people with PSC.

Participants in the study will receive either pyridoxine or a placebo for a period of 12 weeks. After this phase, they will switch to the other treatment for another 12 weeks. This approach helps researchers compare the effects of the actual treatment against the placebo. The study will monitor changes in various health markers, including liver function tests and other indicators of liver health, to assess the impact of pyridoxine on PSC.

The trial will also evaluate the safety of pyridoxine by recording any adverse events or side effects experienced by participants. By the end of the study, researchers hope to gather enough information to understand whether pyridoxine can be a beneficial treatment option for individuals with Primary Sclerosing Cholangitis.

Study of Oral Vancomycin for Adults and Young Adults with Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 14:25:34 +0000

This clinical trial is focused on studying the effects of a medication called vancomycin on a liver disease known as Primary Sclerosing Cholangitis (PSC). PSC is a condition that causes inflammation and scarring of the bile ducts, which can lead to liver damage. Some patients with PSC also have another condition called Inflammatory Bowel Disease (IBD), which affects the digestive tract. The study will compare the effects of oral vancomycin with a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to see how vancomycin affects a specific liver enzyme called alkaline phosphatase (ALP) over a period of six months. Participants in the study will be randomly assigned to receive either vancomycin or the placebo. The study will include regular check-ups and tests to monitor the participants’ health and the effects of the treatment. These tests will include blood tests to measure liver enzymes and other markers, as well as assessments of the participants’ overall health and any side effects they may experience.

The study will also look at other factors, such as changes in liver function, the progression of liver disease, and the impact on IBD symptoms for those who have it. The goal is to gather information on the safety and effectiveness of vancomycin for treating PSC, with or without IBD, and to see if it can help improve liver health and quality of life for patients with these conditions.

Study on the Safety and Tolerability of A3907 for Adults with Primary Sclerosing Cholangitis (PSC)

Wed, 29 Apr 2026 14:25:00 +0000

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts inside and outside the liver become inflamed and scarred, which can lead to liver damage over time. The study is testing a new treatment called A3907, which is taken as a film-coated tablet. The purpose of the study is to evaluate how safe and tolerable A3907 is for adults with PSC, both with and without a condition known as a Clinically Relevant Stricture (CRS), which is a significant narrowing of the bile ducts.

Participants in the study will take the medication orally for a period of 12 weeks. During this time, researchers will monitor the participants to see how their bodies respond to the treatment. This includes checking for any side effects and measuring various health indicators, such as liver function and bile acid levels in the blood and urine. The study aims to gather information on how the body processes the medication and its effects on the liver and bile acids.

The study is open-label, meaning both the participants and the researchers know which treatment is being administered. This trial is part of a Phase 2 study, which is an early stage of clinical research that focuses on assessing the treatment’s safety and how well it is tolerated by patients. The results will help determine if A3907 is a viable treatment option for people with PSC and provide valuable insights into its potential benefits and risks.

Study on Volixibat for Treating Itching in Patients with Primary Sclerosing Cholangitis

Wed, 29 Apr 2026 14:23:54 +0000

This clinical trial is focused on studying a condition called Primary Sclerosing Cholangitis (PSC), which is a disease that affects the bile ducts in the liver and can cause itching, known as pruritus. The study is testing a new treatment called volixibat, which is taken as a hard capsule by mouth. Volixibat is an investigational drug, meaning it is still being studied and is not yet approved for general use. It works as an ileal bile acid transporter inhibitor, which means it helps to reduce the amount of bile acid in the body, potentially easing the itching associated with PSC.

The purpose of the study is to evaluate how effective and safe volixibat is compared to a placebo in treating the itching caused by PSC. Participants in the study will be randomly assigned to receive either volixibat or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for a period of time, during which participants will take the medication and attend regular study visits to monitor their condition and any changes in their symptoms.

Throughout the study, the main focus will be on observing changes in the severity of itching using a tool called the Adult ItchRO. This tool helps to measure how the itching affects daily life. The study aims to provide valuable information on whether volixibat can effectively reduce itching in people with PSC, potentially leading to a new treatment option for this challenging condition.

Study on Norucholic Acid for Treating Primary Sclerosing Cholangitis in Patients

Wed, 29 Apr 2026 14:23:07 +0000

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. The trial is testing a treatment using a medication called norursodeoxycholic acid, also known as norucholic acid or NUC01. This medication is a synthetic form of a bile acid and is taken in the form of hard capsules. The study will compare the effects of NUC01 with a placebo to see if it can help prevent the progression of PSC.

The purpose of the study is to determine if NUC01 is more effective than a placebo in treating PSC. Participants in the study will be randomly assigned to receive either the NUC01 capsules or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for a period of time, during which participants will take the medication and have regular check-ups to monitor their health and the progression of the disease.

Throughout the study, the main goal is to observe whether there is a partial normalization of a liver enzyme called s-ALP and to ensure there is no worsening of the disease stage. Secondary observations will include liver stiffness, fibrosis stage, liver histology, and quality of life. The study aims to provide valuable information on the effectiveness of NUC01 in managing PSC and potentially improving the lives of those affected by this condition.