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โ† Trials
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Biochemical Response and Clinical Outcomes in Patients With PBC

Recruitingn/aAges 18 Years - 85 YearsAllRenJi Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Only observation
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Where

1 site
RenJi Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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