Primary biliary cholangitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients meeting the inclusion criteria all conform to the diagnostic criteria of the Practice Guidance for PBC issued by the American Association for the Study of Liver Diseases in 2018: 1) Laboratory tests of serum biochemistry show elevated alkaline phosphatase; 2). Positive anti - mitochondrial antibody or, when AMA is negative, positive for other specific antibodies of PBC (gp210, sp100); 3). Liver histological evidence suggests the presence of non - suppurative destructive cholangitis and interlobular bile duct damage; Diagnosis of PBC can be made if two of the above three criteria are met. 2. Follow-up duration >= 6 months; 3. Clinical data completeness > 70%
Exclusion criteria
Exclusion criteria: 1. Combine with other liver diseases, such as alcoholic liver disease, viral hepatitis, drug-induced liver injury, and other autoimmune liver diseases, etc. 2.Unable to judge the clinical efficacy, those who did not take the medicine as prescribed, and those with incomplete medical records; 3. Pregnant women, lactating women, or those with a plan to have children during the study period; 4. Those who have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin, etc.) for more than 2 weeks within 6 months before screening, and those who have taken hormones for a long time; 5. Those with a history of severe heart, cerebrovascular, kidney, respiratory system diseases or organ failure, as well as mental diseases (including mental diseases caused by alcohol and drug abuse); 6. Other situations that the researcher deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether there is PBC progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Countries
China
Contacts
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology