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
This trial does not accept healthy volunteersQualifiers
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 population
This program will be conducted at a single medical center in Shanghai, Mainland China. The sample size of subjects will be 3000 PBC patients.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Only observation
Other interventionNo intervention is needed.
Treatment groups
3,000 Participants
are divided into 3 treatment groupsGroup A: Group 1: AKP<1*ULN1 intervention
Group B: Group 2: AKP<1.67*ULN and >1*ULN1 intervention
Group C: Group 3: AKP>1.67*ULN1 intervention
Trial outcomes
Primary outcomes
1
Rate of complication-free survival
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.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov