German PBC Cohort
- Conditions
- Primary biliary cholangitis
- Registration Number
- DRKS00029287
- Lead Sponsor
- niversitätsklinikum Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1200
PBC diagnosis, as demonstrated by the presence of at least two of the following three diagnostic factors: ALP, AMA, liver biopsy. Medication based treatment with at least one drug approved in Germany for the treatment of PBC. Availability of all following essential parameters at the initial diagnosis of PBC prior to the initiation of treatment with UDCA, 12 months after initiation of UDCA and if applicable at time point of secondary incomplete response: Platelet count, ALP, Total Bilirubin, AST/GOT, Age at initial diagnosis of PBC. Patients must meet criteria of one of the cohorts within this NIS. Written statement of consent.
Current participation in a phase I to IV interventional clinical trial for PBC or current participation in another PBC registry
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main objective is to describe the course of PBC in patients in Germany under routine treatment with approved drugs. Therefore, the effectiveness and safety/tolerability of PBC treatment options in a real-life setting will be evaluated.
- Secondary Outcome Measures
Name Time Method Further concomitant aspects of interest may be addressed given an appropriately complete documentation and/or sufficient frequencies of event occurrence within the study cohort.