A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis

What this Trial Is About

Primary biliary cholangitis (PBC) is an autoimmune liver disease that mainly affects middle-aged women and has become more commonly recognized due to advances in specific auto-antibody testing. Despite existing single-center studies exploring PBC prognosis in China, limitations remain such as lack of consideration for symptoms, disease stages, and second-line treatments. This multicenter, large-scale study aims to better understand the characteristics, symptom burden, treatment responses, and long-term survival of PBC patients in China. This study is a retrospective-prospective cohort investigation enrolling about 4,000 PBC patients from ten centers across various provinces and cities in China. It observes a broad PBC patient group without specific experimental treatments. The focus includes evaluating biochemical response to ursodeoxycholic acid (UDCA), symptom prevalence such as fatigue and pruritus, and the impact of second-line therapies. Study data will be gathered from patient records and follow-ups covering many years. Participants will be monitored for outcomes including death and liver transplantation from January 2000 to December 2029, alongside liver-related adverse events up to December 2025. The study involves collecting clinical characteristics, biochemical and laboratory data, and symptom assessments to evaluate disease progression and treatment responses. Researchers will analyze these findings to inform individualized treatment strategies and improve understanding of long-term outcomes for PBC patients in China.

PBC Long-term Outcomes Study