Biochemical response and health outcomes in people with primary biliary cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Saroglitazar Magnesium-V as add-on therapy for primary biliary cholangitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.