NCT07449793Recruiting
Biochemical Response and Clinical Outcomes in Patients With PBC
Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT07449793
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Feb 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
Other
- Female subjects who is pregnant or breastfeeding during the study;
- Poor adherence or inability to complete the study follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RenJi Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.