Actively Recruiting
Biochemical Response and Clinical Outcomes in Patients With PBC
Led by RenJi Hospital · Updated on 2026-03-04
3000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biochemical Response and Clinical Outcomes in Patients With PBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18 years old, male or female
- Diagnosis of Primary Biliary Cholangitis (PBC) according to 2018 AASLD Practice Guidelines
- Treatment with ursodeoxycholic acid (UDCA) at a standard dose (13-15 mg/kg/day), with or without other second-line medications
You will not qualify if you...
- Co-existing liver diseases such as Hepatitis C virus infection or active Hepatitis B infection (except patients who are HBsAg-negative and HBeAg-negative as assessed by the investigator)
- Autoimmune Hepatitis (AIH), Primary Sclerosing Cholangitis (PSC), or suspected/confirmed hepatocellular carcinoma
- Pregnant or breastfeeding females
- History of other malignancies, including hematological tumors or solid tumors excluding hepatobiliary system
- Poor adherence or inability to complete the study follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
M
Min Lian, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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