Congenital absence of bile ducts – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Thu, 18 Jun 2026 04:07:59 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Congenital absence of bile ducts – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Efficacy and Safety Evaluation of Odevixibat in Pediatric Biliary Atresia Post-Kasai Hepatoportoenterostomy: A Double-Blind, Randomized, Placebo-Controlled Trial https://clinicaltrials.eu/trial/efficacy-and-safety-evaluation-of-odevixibat-in-pediatric-biliary-atresia-post-kasai-hepatoportoenterostomy-a-double-blind-randomized-placebo-controlled-trial/ Thu, 18 Jun 2026 04:07:59 +0000 https://clinicaltrials.eu/trial/efficacy-and-safety-evaluation-of-odevixibat-in-pediatric-biliary-atresia-post-kasai-hepatoportoenterostomy-a-double-blind-randomized-placebo-controlled-trial/ This clinical trial is focused on studying Biliary Atresia, a condition affecting the liver and bile ducts in children. The study will evaluate the effectiveness and safety of a medication called Odevixibat (also known by its code name A4250). This medication is taken in the form of a capsule and is designed to help improve liver function in children who have undergone a surgical procedure called Kasai Hepatoportoenterostomy, which is performed to treat Biliary Atresia.

The purpose of the study is to compare the effects of Odevixibat with a placebo in children with Biliary Atresia. Participants will receive either Odevixibat or a placebo once daily. The study will last for up to 104 weeks, during which time the health of the participants will be closely monitored. The main focus will be on the time it takes for participants to require a liver transplant or experience other serious health issues related to their liver condition.

Throughout the study, various health parameters will be assessed, including liver function tests and overall health status. The study aims to provide valuable information on whether Odevixibat can help improve the outcomes for children with Biliary Atresia who have had the Kasai procedure. Participants will be regularly checked for any side effects or changes in their health to ensure their safety during the trial.

]]> Study on Obeticholic Acid for Children with Biliary Atresia After Kasai Procedure https://clinicaltrials.eu/trial/study-on-obeticholic-acid-for-children-with-biliary-atresia-after-kasai-procedure/ Wed, 29 Apr 2026 14:30:09 +0000 https://clinicaltrials.eu/trial/study-on-obeticholic-acid-for-children-with-biliary-atresia-after-kasai-procedure/ This clinical trial is focused on studying a condition called biliary atresia, which affects the liver and bile ducts in children. The study is specifically for children who have undergone a surgical procedure known as hepatoportoenterostomy, or the Kasai procedure, which is performed to help restore bile flow. The treatment being tested in this study is a medication called obeticholic acid, also known by its code name INT-747. This medication is being compared to a placebo to evaluate its effectiveness and safety in treating biliary atresia.

The purpose of the study is to assess how well obeticholic acid works in improving clinical outcomes for children with biliary atresia who have had a successful Kasai procedure. The study will monitor various health events such as the need for a liver transplant, changes in liver disease severity, and hospitalizations due to complications like bleeding or infections. The study will also look at how the body processes the medication and its effects on liver function and other health markers.

Participants in the study will receive either obeticholic acid or a placebo in the form of tablets. The study will be conducted over a period of time, with regular check-ups to monitor the participants’ health and any side effects. The goal is to gather information on the safety and potential benefits of obeticholic acid for children with biliary atresia, which could lead to improved treatment options in the future.

]]> Study on Long-term Effects and Safety of Odevixibat in Children with Biliary Atresia https://clinicaltrials.eu/trial/study-on-long-term-effects-and-safety-of-odevixibat-in-children-with-biliary-atresia/ Wed, 29 Apr 2026 14:25:09 +0000 https://clinicaltrials.eu/trial/study-on-long-term-effects-and-safety-of-odevixibat-in-children-with-biliary-atresia/ This clinical trial is focused on studying the long-term effects of a medication called odevixibat (also known by its code name A4250) in children with a liver disease known as biliary atresia. Biliary atresia is a condition that affects the bile ducts, which are tubes that carry bile from the liver to the gallbladder. In this disease, the bile ducts are blocked or absent, leading to liver damage. The purpose of the study is to evaluate how well odevixibat works over a long period and to ensure it is safe for children with this condition.

Participants in the study will take odevixibat in the form of a capsule, which is taken by mouth. The study will follow the children over a period of time to monitor their liver health and overall growth. The main focus will be on how long the children can maintain their liver function without needing a liver transplant or experiencing severe liver problems. The study will also look at changes in certain blood tests that indicate liver health, as well as the children’s growth and development compared to standard growth charts.

The study is an extension of a previous trial, meaning it will continue to observe children who have already been taking odevixibat to see if the benefits are sustained over time. The researchers will collect data at various points throughout the study to assess the medication’s impact on liver health and overall well-being. This information will help determine if odevixibat is a viable long-term treatment option for children with biliary atresia.

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