Biochemical Response and Clinical Outcomes in Patients With PBC
Recruiting now
Conditions studied: Primary Biliary Cholangitis (PBC), Primary Biliary Cholangitis
In brief
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients. The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.
Key facts
- Study ID
- NCT07449793
- Run by
- RenJi Hospital
- People needed
- 3000
- Starts
- 2026-02-01
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age above 18 years old, Male or Female,
- Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;
- Treatment with UDCA at a standard dose (13-15 mg/kg/day), with or without other second-line medications.
You may not qualify if…
- Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment);
- Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;
- Female subjects who is pregnant or breastfeeding during the study;
- History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
- Poor adherence or inability to complete the study follow-up.
Where it is running
- RenJi Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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