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.



Belgium
Bulgaria
Czechia
France
Germany
Greece
Italy
Poland
Spain