Clinical Research of Tapering UDCA in PBC Patients With a Complete Response

This study is investigating whether patients with primary biliary cholangitis (PBC) — an autoimmune liver disease — who have achieved a complete biochemical response to their standard treatment with ursodeoxycholic acid (UDCA) can safely reduce their dose. PBC is a long-term condition that damages bile ducts in the liver, and UDCA is the main therapy. Some patients maintain stable liver function for years and may not need the full dose indefinitely, but this has not been formally studied. Participants will have their UDCA dose gradually tapered (reduced) while being closely monitored with regular blood tests to check liver function. This is an important study because long-term medication reduction could improve quality of life and reduce side effects. **You may be eligible if you:** - Are 18 years of age or older - Have a confirmed diagnosis of PBC (by AASLD 2000 criteria) - Are in clinical stage 2 or 3 of the disease - Have had improved liver function tests (ALP and AST at or below 1.5x upper normal, with normal bilirubin) after 6–12 months on UDCA - Have provided informed consent **You may NOT be eligible if you:** - Have another liver condition (e.g., hepatitis B or C, alcoholic cirrhosis) - Have liver ALT or AST more than twice the upper limit of normal - Have decompensated liver disease (Child Grade B or C) - Have significant organ failure, active infection, or other serious complications - Are pregnant, breastfeeding, or planning pregnancy - Are currently in another clinical trial **Talk to your doctor** if you have primary biliary cholangitis and have been stable on UDCA therapy for some time.