Biochemical Response and Clinical Outcomes in Patients With PBC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorRenJi Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Only observation
Treatment groups
3,000 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov