Biochemical Response and Clinical Outcomes in Patients With PBC

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.

Recruiting

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Key information

Conditions

Primary Biliary Cholangitis (PBC) Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Biliary Cholangitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

Location status: Recruiting

Location contact

Min Lian, MD, PhD

CONTACT

[email protected]

+8615800744783

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Only observation

Other

No intervention is needed.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lian, MD, PhD

CONTACT

[email protected]

+8615800744783

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Mar 4, 2026
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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