Primary biliary cholangitis
Conditions
Interventions
Group 1: Group 1 - Incomplete Responder n -250 is a non-interventional study, beside the letter of acceptance, are there no additional measures for the study participants - only data processing
Sponsors
Universitätsklinikum Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: Current participation in a phase I to IV interventional clinical trial for PBC or current participation in another PBC registry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Further concomitant aspects of interest may be addressed given an appropriately complete documentation and/or sufficient frequencies of event occurrence within the study cohort. | — |
Countries
Germany
Contacts
Public ContactJohannes Wiegand
Universitätsklinikum Leipzig
Outcome results
None listed