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Clinical Trials for Primary Sclerosing Cholangitis

There are currently 10 ongoing clinical trials for Primary Sclerosing Cholangitis. These trials are testing different medications and approaches to treat this chronic liver disease that affects the bile ducts. The trials are being conducted across multiple European countries, including Germany, France, Italy, Spain, Poland, Sweden, Norway, Denmark, Austria, Netherlands, Belgium, Portugal, Finland, and Hungary. Researchers are investigating various treatments including antibiotics, vitamins, statins, bile acid derivatives, and other novel medications to help improve liver function, reduce symptoms like itching, and slow disease progression.

Clinical trial locations

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

This trial is taking place in Italy and is testing whether oral vancomycin, an antibiotic typically used to treat intestinal infections, can help people with Primary Sclerosing Cholangitis. The study is examining whether this medication can lower levels of alkaline phosphatase, a liver enzyme that is often elevated in patients with this condition.

Who can participate: Adults and young people aged 15 to 70 years with confirmed large-duct Primary Sclerosing Cholangitis and alkaline phosphatase levels at least 1.5 times above normal. Participants may or may not have Inflammatory Bowel Disease alongside their condition. Those taking ursodeoxycholic acid or similar medications must maintain stable doses throughout the study.

Who cannot participate: People with other liver diseases, those who have had a liver transplant, individuals with severe heart problems or uncontrolled diabetes, pregnant or breastfeeding women, and anyone currently in another clinical trial are excluded.

What the trial involves: Participants will be randomly assigned to receive either oral vancomycin or a placebo for six months. Regular check-ups will include blood tests to monitor liver enzymes and overall health. The study aims to see if vancomycin can improve liver function and quality of life for people with this condition.

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

This trial is being conducted in Germany and is testing low-dose Interleukin-2, also called aldesleukin, in people with several chronic inflammatory conditions including Primary Sclerosing Cholangitis. The medication is given as an injection under the skin.

Who can participate: Adults aged 18 to 80 with confirmed Primary Sclerosing Cholangitis and alkaline phosphatase levels at least 1.5 times above normal. Those with Inflammatory Bowel Disease alongside their condition are also welcome to join.

Who cannot participate: Pregnant or breastfeeding women, people with severe allergic reactions to similar treatments, those with active infections requiring treatment, individuals with a history of cancer in the last five years (except certain skin cancers), people with significant heart problems, uncontrolled high blood pressure, severe liver or kidney disease, or recent participation in another trial are excluded.

What the trial involves: The study aims to see if low-dose aldesleukin is safe and can increase regulatory T cells in the body, which help control inflammation. Participants receive treatment for eight weeks with regular monitoring of immune responses and disease symptoms.

Study on Pyridoxine for Patients with Primary Sclerosing Cholangitis

This Norwegian trial is examining whether pyridoxine, also known as vitamin B6, can help reduce elevated alkaline phosphatase levels in people with Primary Sclerosing Cholangitis.

Who can participate: Adults aged 18 to 75 who speak Norwegian and have confirmed large-duct Primary Sclerosing Cholangitis with alkaline phosphatase levels above normal. Participants must have had at least one colonoscopy, with more recent ones required if they also have Inflammatory Bowel Disease. Stable doses of current medications for at least 12 weeks are required.

Who cannot participate: People with other liver conditions, those outside the specified age range, vulnerable populations, individuals unable to follow study procedures, and those currently in another trial are excluded.

What the trial involves: The study lasts 24 weeks with a crossover design, meaning participants will receive both pyridoxine and placebo at different times. This is followed by an additional 24-week open-label phase where all participants receive pyridoxine at different doses. Regular monitoring includes liver function tests and assessments of symptoms like fatigue and itching.

Study on Simvastatin for Treating Primary Sclerosing Cholangitis in Patients

This Swedish trial is testing simvastatin, a medication typically used to lower cholesterol, to see if it can help prolong the time patients live without developing serious complications like bile duct cancer, variceal bleeding, or needing a liver transplant.

Who can participate: Adults aged 18 to 75 with confirmed Primary Sclerosing Cholangitis who have had a recent MR/MRCP scan. Those with or without Inflammatory Bowel Disease can participate, with recent colonoscopy required for those with known IBD. Women of childbearing potential must agree to use effective birth control.

Who cannot participate: People with other liver conditions, those who have had a liver transplant, individuals with a history of bile duct cancer or variceal bleeding, pregnant or breastfeeding women, and those currently in another trial are excluded.

What the trial involves: Participants will receive either simvastatin 40 mg or placebo daily in a double-blind study. The trial will continue until September 2030, with regular monitoring of liver function tests, imaging results, and development of complications.

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

This large international trial is taking place across ten European countries: Denmark, Poland, Austria, Sweden, Netherlands, Germany, Belgium, France, Hungary, and Norway. It is testing norucholic acid, a synthetic bile acid, to evaluate its safety and how well it is tolerated in patients with Primary Sclerosing Cholangitis.

Who can participate: Adults aged 18 or older who have been previously diagnosed with Primary Sclerosing Cholangitis and participated in a previous trial called NUC 5/PSC. Women who can have children must use highly effective birth control during the study and for four weeks after the last dose.

Who cannot participate: People with other liver conditions, those not within the specified age range, individuals unable to take the medication in tablet form, pregnant or breastfeeding women, those participating in another trial, people with allergies to similar medications, and those with a history of substance abuse or serious mental health conditions are excluded.

What the trial involves: Participants take norucholic acid tablets orally with regular monitoring for any side effects, changes in vital signs, body weight, liver stiffness, and blood test results. The study is expected to end on September 30, 2027.

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

This French trial is examining whether bezafibrate can help patients who continue to have cholestasis, a reduction or stoppage of bile flow, despite being treated with the standard medication ursodeoxycholic acid.

Who can participate: Adults aged 18 to 75 with confirmed Primary Sclerosing Cholangitis who have been taking ursodeoxycholic acid for at least six months at a specific dose. Participants must have alkaline phosphatase levels at least 1.5 times above normal and have had a recent colonoscopy showing no cancer or abnormal cell growth. Women who can have children must use reliable birth control.

Who cannot participate: Those without confirmed Primary Sclerosing Cholangitis, people outside the specified age range, vulnerable populations, individuals unable to take the medication or follow study procedures, pregnant or breastfeeding women, and those currently in another trial are excluded.

What the trial involves: Participants are randomly assigned to receive either bezafibrate 400 mg or placebo once daily for 24 months, in addition to their standard ursodeoxycholic acid therapy. The trial is double-blind, with regular monitoring of liver function, liver stiffness, and symptoms such as itching and fatigue.

Study on Norucholic Acid for Treating Primary Sclerosing Cholangitis in Patients

This large international trial is taking place in nine European countries: Denmark, Austria, Norway, Finland, Germany, Netherlands, France, Hungary, and Poland. It is testing norursodeoxycholic acid (norUDCA), a synthetic bile acid, to determine if it can prevent the progression of Primary Sclerosing Cholangitis.

Who can participate: Adults of any age with confirmed Primary Sclerosing Cholangitis who have a liver biopsy available. Women who can have children must use highly effective birth control during the study and for four weeks after the last dose. Participants must also agree to continue in an open-label extension phase.

Who cannot participate: People with other liver diseases, those who have had a liver transplant, individuals currently taking interfering medications, people with a history of alcohol or drug abuse, pregnant or breastfeeding women, those with serious medical conditions, people who participated in another trial within the last 30 days, and those unable to follow study procedures are excluded.

What the trial involves: Participants are randomly assigned to receive either norursodeoxycholic acid or placebo in hard capsule form in a double-blind study. The main goal is to observe whether there is improvement in alkaline phosphatase levels and no worsening of disease stage. The trial includes regular visits to monitor liver function, liver stiffness, and quality of life.

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

This trial is being conducted in Spain, Portugal, Germany, and Italy, testing elafibranor, a medication that activates certain proteins in the body that may help improve liver function.

Who can participate: Adults aged 18 to 75 with confirmed Primary Sclerosing Cholangitis, showing historical evidence of elevated alkaline phosphatase for at least 6 months and current levels at least 1.5 times above normal. Those with Inflammatory Bowel Disease can participate if their condition is in remission or shows low activity. Participants taking ursodeoxycholic acid must be on a stable dose.

Who cannot participate: People with other liver conditions, those outside the specified age range, pregnant or breastfeeding women, individuals who participated in another trial recently, and those unable to follow study procedures are excluded.

What the trial involves: Participants are randomly assigned to receive elafibranor at 80 mg or 120 mg, or placebo, taken daily as a film-coated tablet for 12 weeks in a double-blind study. This may be followed by an open-label extension where participants receive elafibranor up to 120 mg daily for longer-term safety evaluation. Regular monitoring includes liver function tests and other health indicators.

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

This trial is being conducted in Poland, Italy, France, and Spain, testing a new medication called A3907 in adults with Primary Sclerosing Cholangitis, including those with and without narrowing of the bile ducts.

Who can participate: Adults aged 18 to 75 with a confirmed diagnosis of large-duct Primary Sclerosing Cholangitis for more than 6 months, with alkaline phosphatase levels more than 1.5 times above normal. Those with Inflammatory Bowel Disease can participate if their condition is in remission or shows mild activity. Use of ursodeoxycholic acid is allowed if the dose has been stable for at least 3 months.

Who cannot participate: People with other serious liver diseases, those who have had a liver transplant, individuals with a history of cancer in the last 5 years (except certain skin cancers), pregnant or breastfeeding women, those currently in another trial, people with known allergies to the study medication, and those with severe heart, kidney problems, or uncontrolled diabetes are excluded.

What the trial involves: Participants take A3907 as a film-coated tablet orally for 12 weeks in an open-label study. Regular monitoring includes checking for side effects and measuring changes in bile acid levels, liver function tests, and other health indicators. The study aims to assess the safety and how well the medication is tolerated.

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

This trial is taking place in Germany, Belgium, France, Spain, Netherlands, and Italy, testing volixibat to see if it can reduce the itching that many people with Primary Sclerosing Cholangitis experience. Volixibat works as an ileal bile acid transporter inhibitor, which helps reduce bile acid in the body.

Who can participate: People aged at least 12 years in eligible regions or at least 18 years otherwise, with confirmed Primary Sclerosing Cholangitis and an average daily itching score of at least 1 during the two weeks before the second visit. Use of ursodeoxycholic acid and anti-itch medication is allowed under certain conditions, as is having Inflammatory Bowel Disease at the same time.

Who cannot participate: Those who do not have itching associated with Primary Sclerosing Cholangitis, people not within the specified age range, and those not included in the selected study groups are excluded.

What the trial involves: Participants are randomly assigned to receive either volixibat or placebo as hard capsules in a double-blind study. Regular assessments measure changes in itching severity using the Adult ItchRO tool. The trial aims to determine if volixibat can effectively reduce itching and improve quality of life for those affected.

Summary

Primary Sclerosing Cholangitis remains a challenging liver disease with limited treatment options. These ten clinical trials represent significant efforts to find new treatments that can improve liver function, reduce symptoms, and slow disease progression. The trials test a diverse range of approaches, from repurposing existing medications like vancomycin, simvastatin, and vitamin B6 to investigating novel bile acid derivatives like norucholic acid.

Several trials focus on norucholic acid, taking place across multiple European countries, indicating strong scientific interest in this synthetic bile acid as a potential treatment. Other trials are exploring medications that target different aspects of the disease, including immune system modulation with aldesleukin, symptom relief with volixibat for itching, and metabolic regulation with elafibranor and bezafibrate.

The trials are distributed across many European countries, with France, Germany, and Italy hosting the most studies. This wide geographic distribution helps ensure diverse patient populations and robust research findings. Most trials welcome participants with or without Inflammatory Bowel Disease, recognizing the common association between these conditions.

Many trials require participants to have elevated alkaline phosphatase levels, a key marker of the disease, and some allow continued use of ursodeoxycholic acid, the current standard treatment. The studies vary in duration from 12 weeks to several years, reflecting different research objectives from initial safety assessment to long-term disease management.

Ongoing Clinical Trials on Cholangitis sclerosing

  • Study on Simvastatin for Treating Primary Sclerosing Cholangitis in Patients

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    Sweden

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