Biochemical response and health outcomes in people with primary biliary cholangitis
Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
We will follow adults with primary biliary cholangitis who are taking ursodeoxycholic acid (UDCA) to see if their alkaline phosphatase levels after treatment predict how long they stay free of complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07449793 on ClinicalTrials.gov |
What this trial studies
This is a bidirectional cohort study using a mainland China database at RenJi Hospital that continuously collects demographics, symptoms, and biochemical data from diagnosed PBC patients. Investigators will track post-treatment alkaline phosphatase (AKP/ALP) levels in patients treated with standard-dose UDCA and record complication-free survival outcomes. The team will analyze the association between different post-treatment ALP levels and time to complications and will develop a predictive survival model. The work is observational and aims to validate prognostic markers within this Chinese patient cohort.
Who should consider this trial
Good fit: Adults (≥18 years) with a confirmed PBC diagnosis per the 2018 AASLD criteria who are receiving standard-dose UDCA (13–15 mg/kg/day) and can complete study follow-up are ideal candidates.
Not a fit: Patients with other active liver diseases (such as active hepatitis B or C, autoimmune hepatitis, or primary sclerosing cholangitis), suspected hepatocellular carcinoma, recent other malignancies, pregnant or breastfeeding women, or those not on standard-dose UDCA or unable to adhere to follow-up are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the results could help clinicians identify patients at higher risk of complications and tailor monitoring or treatment decisions accordingly.
How similar studies have performed: Previous research has shown that post-treatment alkaline phosphatase levels correlate with outcomes in PBC and several prognostic models exist, though validation in a mainland China cohort is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Shanghai, Shanghai Municipality
- RenJi Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiong Ma, MD, PhD — RenJi Hospital
- Study coordinator: Min Lian, MD, PhD
- Email: sophialian24@163.com
- Phone: +8615800744783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.