This clinical trial is focused on studying the effects of a treatment for cholestatic pruritus, a condition characterized by severe itching due to liver problems. The treatment being tested is called Maralixibat chloride, which is taken as an oral solution. This medication works as an ileal bile acid transporter (IBAT) inhibitor, which means it helps to reduce the amount of bile acids in the body that can cause itching.
The purpose of the study is to evaluate how effective Maralixibat chloride is compared to a placebo in reducing the severity of itching in participants with cholestatic pruritus. Participants in the study will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for a period of 40 weeks, during which participants will take the oral solution and attend regular study visits to monitor their condition and any changes in their symptoms.
Throughout the study, participants will be asked to report on their itching symptoms using a tool called the Itch-Reported Outcome (ItchRO), which helps to measure the severity of their itching. The study aims to see if there is a significant improvement in the itching symptoms of those taking Maralixibat chloride compared to those taking the placebo. This research is important for finding better ways to manage and treat the discomfort associated with cholestatic pruritus.



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