NCT07449793 Biochemical Response and Clinical Outcomes in Patients With PBC
| NCT ID | NCT07449793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Primary Biliary Cholangitis (PBC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2026-02-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Xiong Ma, MD, PhD
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT07449793 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Primary Biliary Cholangitis (PBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07449793 currently recruiting?
Yes, NCT07449793 is actively recruiting participants. Contact the research team at sophialian24@163.com for enrollment information.
Where is the NCT07449793 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07449793 clinical trial?
NCT07449793 is sponsored by RenJi Hospital. The principal investigator is Xiong Ma, MD, PhD at RenJi Hospital. The trial plans to enroll 3,000 participants.