Primary Biliary Cholangitis, Primary Biliary Cholangitis (PBC)
Conditions
Keywords
Primary Biliary Cirrhosis, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases, Cholangitis, Biliary, Cirrhosis, Biliary, Chronic Nonsuppurative Destructive Cholangitis
Brief 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.
Interventions
OTHEROnly observation
No intervention is needed.
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complication-free survival | 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. |
Countries
China
Contacts
CONTACTMin Lian, MD, PhD
PRINCIPAL_INVESTIGATORXiong Ma, MD, PhD
RenJi Hospital
Outcome results
None listed