Primary biliary cholangitis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Thu, 18 Jun 2026 04:07:07 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Primary biliary cholangitis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study of Seladelpar Treatment in Patients with Primary Biliary Cholangitis and Compensated Cirrhosis https://clinicaltrials.eu/trial/study-on-the-effects-of-seladelpar-for-patients-with-primary-biliary-cholangitis-and-compensated-cirrhosis/ Wed, 29 Apr 2026 15:06:02 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-seladelpar-for-patients-with-primary-biliary-cholangitis-and-compensated-cirrhosis/ This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The study will test a medication called seladelpar in patients who have PBC with compensated cirrhosis, which means scarring of the liver that is still functioning. The purpose is to determine if seladelpar can improve health outcomes in these patients compared to placebo.

The medication will be given as oral capsules in two different strengths – 5 mg and 10 mg. The study will last for 156 weeks (about 3 years). During this time, researchers will monitor various aspects of liver health and complications that can occur with liver disease, such as ascites (fluid buildup in the abdomen), hepatic encephalopathy (brain function problems caused by liver disease), and esophageal varices (enlarged veins in the food pipe that can bleed).

This is a randomized, double-blind study, which means that patients will be assigned by chance to receive either seladelpar or placebo. Neither the patients nor the doctors will know which treatment each person is receiving. The study will track important health events including survival, need for liver transplantation, and hospitalizations related to liver complications. The medication’s safety will also be carefully monitored throughout the study period.

]]> Study on the Safety and Effectiveness of Saroglitazar Magnesium for Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-saroglitazar-magnesium-for-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 15:03:48 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-saroglitazar-magnesium-for-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study will test a medication called Saroglitazar Magnesium, which is taken as uncoated tablets. The purpose of the study is to evaluate the effectiveness and safety of Saroglitazar Magnesium in treating PBC.

Participants in the study will be randomly assigned to receive either Saroglitazar Magnesium or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about 52 weeks, during which participants will take the medication once daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The main goal is to see if Saroglitazar Magnesium can improve certain liver function tests, specifically the levels of alkaline phosphatase (ALP) and bilirubin, which are indicators of liver health.

By the end of the study, researchers hope to determine if Saroglitazar Magnesium is more effective than the placebo in improving liver function in people with PBC. This information could help in developing better treatments for those living with this chronic liver disease.

]]> Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-obeticholic-acid-and-bezafibrate-for-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 15:03:22 +0000 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-obeticholic-acid-and-bezafibrate-for-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying Primary Biliary Cholangitis (PBC), a chronic disease that affects the liver. The study is evaluating a treatment that combines two medications: Obeticholic Acid and Bezafibrate. These medications are taken together in a single tablet form, known as OCA/BZF FDC, which stands for Fixed-Dose Combination of Obeticholic Acid and Bezafibrate.

The purpose of the study is to assess the long-term safety and tolerability of this combination treatment in individuals with PBC. Participants in the study will take the medication over an extended period, and researchers will monitor various health markers to ensure the treatment is safe and well-tolerated. These markers include levels of certain enzymes and substances in the blood that indicate liver function and bile acid balance.

The study is designed to provide valuable information about how well the treatment works over time and its impact on the health of individuals with PBC. Participants will be observed for changes in their condition, and the study will help determine if the treatment can effectively manage the symptoms and progression of PBC. The trial is open-label, meaning both the researchers and participants know which treatment is being administered, and it is a long-term study to gather comprehensive safety data.

]]> Study on the Effects of Bezafibrate and Obeticholic Acid for Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-the-effects-of-bezafibrate-and-obeticholic-acid-for-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 15:01:21 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-bezafibrate-and-obeticholic-acid-for-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study is testing the effects of two investigational drugs, obeticholic acid (also known as OCA) and bezafibrate (BZF), to see if they can help people with PBC. The purpose of the study is to assess how well these drugs work together in reducing a liver enzyme called alkaline phosphatase (ALP), which is often elevated in people with PBC.

Participants in the study will be randomly assigned to receive either the combination of OCA and BZF or BZF alone. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will last for several weeks, during which participants will take the medication in the form of tablets by mouth. Regular check-ups will be conducted to monitor the participants’ health and the effects of the treatment.

The main goal is to observe changes in ALP levels from the start of the study to the end of the treatment period. Additionally, the study will look at other health markers, such as liver function tests and lipid levels, to evaluate the safety and tolerability of the treatment. The results will help determine if the combination of OCA and BZF is more effective than BZF alone in managing PBC.

]]> Study on Bezafibrate for Patients with Primary Biliary Cholangitis Not Responding Well to Ursodeoxycholic Acid https://clinicaltrials.eu/trial/study-on-bezafibrate-for-patients-with-primary-biliary-cholangitis-not-responding-well-to-ursodeoxycholic-acid/ Wed, 29 Apr 2026 14:59:56 +0000 https://clinicaltrials.eu/trial/study-on-bezafibrate-for-patients-with-primary-biliary-cholangitis-not-responding-well-to-ursodeoxycholic-acid/ This clinical trial is focused on studying the effectiveness and safety of the medication bezafibrate in patients with Primary Biliary Cholangitis (PBC), a liver disease. The study is specifically for those who have not had an optimal response to a standard treatment called ursodeoxycholic acid (UDCA). The trial will test two different doses of bezafibrate: 200 mg and 400 mg, and compare them to a placebo. The purpose of the study is to see if bezafibrate can help improve the condition of patients with PBC who are not responding well to UDCA.

The study will last for a total of 24 months. During the first 12 months, participants will receive either bezafibrate or a placebo in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication. After this period, there will be a 12-month extension phase where all participants will receive bezafibrate, but without the use of a placebo. This approach helps to ensure that the results are reliable and that any improvements can be attributed to bezafibrate.

Throughout the study, participants will be monitored for changes in their liver function and any side effects they may experience. The main goal is to determine if bezafibrate can lead to a complete biochemical response, which means normalizing certain liver enzyme levels. Additionally, the study will look at other factors such as the intensity of itching, which is a common symptom of PBC, and any serious adverse events that may occur. This research aims to provide more information on whether bezafibrate can be a beneficial addition to the treatment of PBC.

]]> Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid https://clinicaltrials.eu/trial/study-on-elafibranor-for-patients-with-primary-biliary-cholangitis-not-responding-to-ursodeoxycholic-acid/ Wed, 29 Apr 2026 14:59:38 +0000 https://clinicaltrials.eu/trial/study-on-elafibranor-for-patients-with-primary-biliary-cholangitis-not-responding-to-ursodeoxycholic-acid/ This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study is testing a medication called elafibranor, which is taken as a film-coated tablet. The purpose of the study is to evaluate the effectiveness and safety of elafibranor in patients with PBC who have not responded well to or cannot tolerate a common treatment called ursodeoxycholic acid.

Participants in the study will be randomly assigned to receive either elafibranor or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a total of 52 weeks, during which the effects of the treatment on the liver will be closely monitored. After this period, there will be an option for participants to continue in an open-label extension, where everyone will receive elafibranor, to further assess its long-term safety and benefits.

The study aims to see if elafibranor can help reduce the levels of certain liver enzymes and improve symptoms such as itching, which is common in PBC. Participants will have regular check-ups and tests to monitor their liver function and overall health throughout the study. This research hopes to provide new insights into managing PBC and improving the quality of life for those affected by this condition.

]]> Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment https://clinicaltrials.eu/trial/study-of-elafibranor-for-adults-with-primary-biliary-cholangitis-who-do-not-respond-well-or-cannot-tolerate-ursodeoxycholic-acid/ Wed, 29 Apr 2026 14:58:55 +0000 https://clinicaltrials.eu/trial/study-of-elafibranor-for-adults-with-primary-biliary-cholangitis-who-do-not-respond-well-or-cannot-tolerate-ursodeoxycholic-acid/ This study focuses on Primary Biliary Cholangitis (PBC), a long-term liver disease that causes the bile ducts in the liver to become damaged. The research evaluates a medication called elafibranor in patients who have not responded well to or cannot tolerate standard treatment with ursodeoxycholic acid. The purpose is to determine if elafibranor can help normalize liver enzyme levels in adults with this condition.

The study will test film-coated tablets containing 80 mg of elafibranor compared to placebo in adult patients. The treatment will be given as a daily oral dose for 52 weeks. During this time, researchers will monitor changes in liver function, particularly focusing on levels of alkaline phosphatase, an enzyme that indicates liver health.

Throughout the study, participants will have their symptoms assessed, including itching severity and quality of life. The research will also track any changes in liver function tests and monitor the overall safety of the treatment. The study uses various questionnaires to measure how participants feel and function during their daily activities while receiving the treatment.

]]> Study of Elafibranor for Adults with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-of-elafibranor-for-adults-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 14:57:17 +0000 https://clinicaltrials.eu/trial/study-of-elafibranor-for-adults-with-primary-biliary-cholangitis/ This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study will test a medication called elafibranor, which is taken as a film-coated tablet. Participants in the study will either receive elafibranor or a placebo tablet, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe elafibranor is for people with PBC. Participants will take the medication daily and will be monitored over a long period to see how it affects their health. The study will look at how long participants remain free from disease progression or other serious health events. It will also track any side effects or changes in health that occur during the study.

Throughout the study, participants will have regular check-ups to monitor their liver function and overall health. This will include physical exams, blood tests, and other assessments to ensure their safety and to gather information on how the treatment is working. The study aims to provide valuable insights into the potential benefits of elafibranor for people living with PBC.

]]> Study on the Effects of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis Who Cannot Tolerate Ursodeoxycholic Acid https://clinicaltrials.eu/trial/study-on-the-effects-of-obeticholic-acid-and-bezafibrate-for-patients-with-primary-biliary-cholangitis-who-cannot-tolerate-ursodeoxycholic-acid/ Wed, 29 Apr 2026 14:28:25 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-obeticholic-acid-and-bezafibrate-for-patients-with-primary-biliary-cholangitis-who-cannot-tolerate-ursodeoxycholic-acid/ This clinical trial is focused on studying a liver disease called Primary Biliary Cholangitis (PBC). PBC is a condition where the bile ducts in the liver become damaged, leading to a buildup of bile that can harm the liver. The study is testing the effects of two investigational drugs, obeticholic acid (also known as OCA) and bezafibrate (BZF), to see if they can help people with PBC who have not responded well to or cannot tolerate another treatment called ursodeoxycholic acid.

The purpose of the study is to evaluate how well the combination of OCA and BZF works compared to BZF alone in managing PBC. Participants in the study will receive either the combination of OCA and BZF, BZF alone, or a placebo. The study will last for about 53 weeks, during which participants will take the medication orally in the form of tablets. The researchers will monitor the participants’ health and liver function throughout the study to assess the safety and effectiveness of the treatment.

During the study, the main focus will be on measuring changes in a liver enzyme called alkaline phosphatase (ALP), which is often elevated in people with PBC. The study will also look at other liver enzymes and substances in the blood to understand the overall impact of the treatment. The goal is to find out if the combination of OCA and BZF can provide better outcomes for people with PBC compared to BZF alone.

]]> Study on the Long-Term Safety of Seladelpar for Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-seladelpar-for-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 14:27:24 +0000 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-seladelpar-for-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying the disease known as Primary Biliary Cholangitis (PBC). PBC is a chronic liver disease that slowly destroys the bile ducts in the liver. The treatment being tested in this study is a medication called Seladelpar, which is taken in capsule form. The study will use two different dosages of Seladelpar: 50 mg and 100 mg capsules. The purpose of the study is to evaluate the long-term safety and tolerability of Seladelpar in individuals with PBC.

Participants in the study will take Seladelpar orally, which means they will swallow the capsules. The study will monitor participants over a period to observe any side effects or changes in their health. This will help researchers understand how well people tolerate the medication over time. The study will also collect information on various health markers, such as liver function tests, to see how the medication affects the body.

Throughout the study, participants will have regular check-ups to ensure their safety and to gather necessary data. The study aims to provide valuable information on the use of Seladelpar for treating PBC, contributing to the understanding of its long-term effects and potential benefits for individuals with this condition.

]]> Study on Volixibat for Treating Itching in Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-volixibat-for-treating-itching-in-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 14:23:43 +0000 https://clinicaltrials.eu/trial/study-on-volixibat-for-treating-itching-in-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying a condition called Primary Biliary Cholangitis (PBC), which is a liver disease that can cause severe itching, known as cholestatic pruritus. The trial is testing a new treatment called volixibat, which is taken as a hard capsule by mouth. The purpose of the study is to evaluate how effective and safe volixibat is in reducing the itching associated with PBC.

Participants in the study will be randomly assigned to receive either volixibat or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The study will last for a period of up to 124 days, during which participants will take the medication daily and attend regular check-ups to monitor their condition and any changes in their symptoms.

The main goal is to see if volixibat can reduce the itching experienced by patients with PBC, as measured by a tool called the Adult ItchRO. Additionally, the study will look at other health indicators, such as changes in certain blood levels and overall quality of life. Participants will be closely monitored for any side effects or adverse reactions to the treatment. The results of this study could provide valuable information about a new potential treatment option for those suffering from PBC-related itching.

]]> Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis https://clinicaltrials.eu/trial/study-on-long-term-safety-of-linerixibat-for-treating-itchy-skin-in-patients-with-primary-biliary-cholangitis/ Wed, 29 Apr 2026 14:23:26 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-linerixibat-for-treating-itchy-skin-in-patients-with-primary-biliary-cholangitis/ This clinical trial is focused on studying the long-term safety and tolerability of a medication called linerixibat for treating a condition known as cholestatic pruritus in people with Primary Biliary Cholangitis (PBC). Cholestatic pruritus is a type of itching that occurs when there is a problem with bile flow in the liver, and PBC is a chronic disease that slowly destroys the bile ducts in the liver. The medication being tested, linerixibat, is taken in the form of tablets.

The purpose of the study is to evaluate how safe and tolerable linerixibat is when used over a long period. Participants in the study will take linerixibat orally, and the study will monitor them for any side effects or adverse events. The study will involve regular check-ups at various intervals, such as weekly, monthly, and every few months, to ensure the safety of the participants and to gather data on how the medication affects them over time.

Throughout the study, participants will be assessed for changes in their health, including any improvements or worsening of their symptoms. The study will also look at how the medication affects participants’ quality of life, including aspects like sleep and fatigue. This trial aims to provide valuable information on the long-term use of linerixibat for individuals with PBC who experience cholestatic pruritus.

]]> Study on Golexanolone for Patients with Primary Biliary Cholangitis Experiencing Fatigue and Cognitive Dysfunction https://clinicaltrials.eu/trial/study-on-golexanolone-for-patients-with-primary-biliary-cholangitis-experiencing-fatigue-and-cognitive-dysfunction/ Wed, 29 Apr 2026 14:22:56 +0000 https://clinicaltrials.eu/trial/study-on-golexanolone-for-patients-with-primary-biliary-cholangitis-experiencing-fatigue-and-cognitive-dysfunction/ This clinical trial is focused on studying a condition called Primary Biliary Cholangitis (PBC), which is a disease that affects the liver. People with PBC often experience significant tiredness and problems with thinking clearly. The trial is testing a new treatment called Golexanolone, which is taken as a capsule. The study will compare the effects of Golexanolone with a placebo to understand its safety, how well it is tolerated, and its initial effectiveness in treating symptoms of PBC.

The study is divided into two parts. In the first part, participants will take a 40 mg dose of Golexanolone twice a day for five days. This part aims to see how safe the treatment is and how well participants can handle it. In the second part, participants will take two different dose levels of Golexanolone twice a day for 28 days. This part will also focus on safety and tolerance, as well as any changes in symptoms like fatigue and cognitive issues.

Throughout the study, researchers will monitor participants for any side effects and changes in their health. They will also look at how the treatment affects quality of life, including aspects like sleepiness and cognitive function. The goal is to gather information that could help improve treatment options for people with PBC in the future.

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