How Blood Test Response to Treatment Relates to Outcomes in Primary Biliary Cholangitis
Follows adults with primary biliary cholangitis to see how treatment response relates to outcomes.
Plain-language title generated from the registry record
Registry title: Biochemical Response and Clinical Outcomes in Patients With PBC
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07449793, who can take part
Where in China
- RenJi HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT07449793
- Record updated
- 4 March 2026
- Original description
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.Read full original descriptionShow less
Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
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.
Inclusion: 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.
Exclusion: 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; History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system; Female subjects who is pregnant or breastfeeding during the study; Poor adherence or inability to complete the study follow-up.