Actively Recruiting
Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
Led by RenJi Hospital · Updated on 2026-03-04
3000
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a bidirectional cohort study to understand outcomes in patients with Primary Biliary Cholangitis (PBC) by analyzing biochemical responses after treatment. The study focuses on the relationship between alkaline phosphatase (AKP) levels following treatment and the patients' complication-free survival rates. The goal is to develop and validate a model that predicts survival based on these biochemical markers. Participants are grouped based on their AKP levels after 12 months of treatment: those with AKP below the upper limit of normal (ULN), those with AKP between 1 and 1.67 times the ULN, and those with AKP above 1.67 times the ULN. The study involves observation only, without additional interventions, and continuously collects demographic, clinical, and biochemical data. During the study, researchers will monitor participants for 18 months to measure the rate of complication-free survival. Data collection includes patient demographics, clinical symptoms, and biochemical tests related to PBC. The study will track outcomes over time to assess how differing biochemical responses relate to patient health and complications, with participation lasting through the follow-up period ending in early 2028.
CONDITIONS
Brief 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 and up to 85 years old
- Male or Female
- Diagnosis of Primary Biliary Cholangitis (PBC) meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria
- 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 investigator)
- Autoimmune Hepatitis (AIH)
- Primary Sclerosing Cholangitis (PSC)
- Suspected or confirmed hepatocellular carcinoma
- Female subjects who are pregnant or breastfeeding during the study
- History of other malignancies, including hematological tumors and solid tumors except 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants who undergo routine care are observed to monitor biochemical response and clinical outcomes over time.
Regular visits as part of routine clinical care
Trial Site Locations
Total: 1 location
1
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
M
Min Lian, MD, PhD
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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