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Recruiting NCT07449793

Biochemical Response and Clinical Outcomes in Patients With PBC

— Observational Primary Biliary Cholangitis (PBC) Primary Biliary Cholangitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Only observation.
Who it may be relevant to
Registry conditions: Primary Biliary Cholangitis (PBC), Primary Biliary Cholangitis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study

Overview

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.

Interventions

  • Other Only observation
    No intervention is needed.

Primary outcome measures

  • Rate of complication-free survival [Time frame: 18 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • RenJi Hospital — Shanghai

Identifiers

NCT: NCT07449793 · PBC2026CH001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗