Status:
UNKNOWN
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
RWTH Aachen University
Zentrum für Klinische Studien Leipzig
Conditions:
PBC
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
Brief Summary
The German PBC Cohort is a multi-centric, observational (non-interventional) study with three parallel groups. The main objective of this observational study is to describe the course of Primary bilia...
Detailed Description
Primary biliary cholangitis (PBC) is a chronic autoimmune cholestatic liver disease. The course of the disease is characterized by a slow destruction of bile ducts, and progressive cholestasis. Progno...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Diagnosis of PBC PBC diagnosis (consistent with AASLD and EASL practice guidelines), as demonstrated by the presence of at least two of the following three diagnostic factors:
- History of elevated ALP levels for 6 months.
- Positive anti-mitochondrial antibody (AMA) titer or if AMA negative or in low titer (\<1:80) =\> PBC-specific antibodies:
- anti-GP210 and/or
- anti-SP100 and/or
- antibodies against the major M2 components \[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex (OADC-E2), branched-chain-2-oxo-acid-dehydrogenase complex, (BCOADC-E2)\].
- Liver biopsy consistent with PBC.
- 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
- Alkaline Phosphatase (ALP)
- Total Bilirubin
- Aspartate aminotransferase (AST/GOT)
- Age at initial diagnosis of PBC
- Patients must meet criteria of one of the cohorts (group 1/2/3) within this NIS according to design
- written statement of informed consent
Exclusion
- Current participation in a phase I to IV interventional clinical trial for PBC or participation in another PBC registry.
Key Trial Info
Start Date :
September 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04076527
Start Date
September 19 2019
End Date
March 1 2024
Last Update
June 7 2023
Active Locations (50)
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1
University Hospital Aachen
Aachen, Germany
2
Charité - Campus Benjamin Franklin
Berlin, Germany
3
Charité-Campus Virchow-Klinikum
Berlin, Germany
4
Internal Practice
Berlin, Germany