The PSC HTD1801 clinical study is for adults between 18-75 years of age who have been diagnosed with Primary Sclerosing Cholangitis for 6 months or more. The purpose of this study is to understand how well a twice a day oral medication (taken by mouth), berberine ursodeoxycholate, referred to as HTD1801, treats PSC.
Primary Sclerosing Cholangitis (PSC) is a rare liver disease that is associated with damage to the bile ducts inside and outside the liver. With PSC, bile ducts become inflamed, often leading to scarring with narrowing of the bile ducts. Over time, blockages may occur and bile is trapped in the liver, leading to liver damage and eventually liver failure.
Clinical studies, also called clinical trials, are conducted to collect data that evaluates the safety and benefit (efficacy) of a new drug in development. All clinical studies must follow a strict set of rules that are outlined in the protocol of the clinical study.