Biochemical Response and Clinical Outcomes in Patients With PBC

February 26, 2026 updated by: ma xiong, RenJi Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Recruiting
        • RenJi Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: AKP<1*ULN
Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment.
Other: Only observation
No intervention is needed.
Group 2: AKP<1.67*ULN and >1*ULN
Patients diagnosed with PBC whose AKP levels are between 1* and 1.67*ULN after 12 months of treatment.
Other: Only observation
No intervention is needed.
Group 3: AKP>1.67*ULN
Patients diagnosed with PBC whose AKP levels exceed 1.67*ULN after 12 months of treatment.
Other: Only observation
No intervention is needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complication-free survival
Time Frame: 18 months
Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Xiong Ma, MD, PhD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC2026CH001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After this observational study is recruited, we are welcome to share the basic demographics and clinical outcomes of recruited IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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