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Biochemical Response and Clinical Outcomes in Patients With PBC | Clinical Trials | Clareo Health

RECRUITING

Biochemical Response and Clinical Outcomes in Patients With PBC

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

NCT07449793•RenJi Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

RenJi Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

February 1, 2026

Primary Completion Date

July 31, 2027

Completion Date

January 31, 2028

Last Updated

March 4, 2026

Enrollment

3,000

ESTIMATED participants

Conditions

Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis

Interventions

Only observation

OTHER

Contacts

Min Lian, MD, PhD

CONTACT

+8615800744783 sophialian24@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biochemical Response and Clinical Outcomes in Patients With PBC

Inclusion Criteria

Exclusion Criteria

A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction

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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy

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