Observational study on Primary Biliary Cholangitis in Germany
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
This study is collecting information from patients with Primary Biliary Cholangitis in Germany to see how well different approved treatments work in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 50 sites (Aachen and 49 other locations) |
| Trial ID | NCT04076527 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the progression and treatment outcomes of patients with Primary Biliary Cholangitis (PBC) in Germany. It involves three parallel groups of patients receiving routine treatment with approved medications, including Ursodeoxycholic acid (UDCA) and Obeticholic acid (Ocaliva). The study will evaluate the effectiveness, safety, and tolerability of these treatments in a real-world clinical setting. By establishing a national registry, the study seeks to better characterize the clinical course of PBC and improve understanding of treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Primary Biliary Cholangitis who are receiving approved medications for their condition.
Not a fit: Patients without a confirmed diagnosis of PBC or those not receiving approved treatments for the condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for PBC, leading to improved patient outcomes and management of the disease.
How similar studies have performed: Other national and international registries have shown success in characterizing PBC, suggesting that this approach could yield valuable insights as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. 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.
3. Medication-based treatment with at least one drug approved in Germany for the treatment of PBC
4. 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
5. Patients must meet criteria of one of the cohorts (group 1/2/3) within this NIS according to design
6. written statement of informed consent
Exclusion Criteria:
Current participation in a phase I to IV interventional clinical trial for PBC or participation in another PBC registry.
Where this trial is running
Aachen and 49 other locations
- University Hospital Aachen — Aachen, Germany (Recruiting)
- Charité - Campus Benjamin Franklin — Berlin, Germany (Recruiting)
- Charité-Campus Virchow-Klinikum — Berlin, Germany (Recruiting)
- Internal Practice — Berlin, Germany (Recruiting)
- Liver Center Checkpoint — Berlin, Germany (Not_yet_recruiting)
- MVZ Gastroenterology — Berlin, Germany (Recruiting)
- Hospital Chemnitz — Chemnitz, Germany (Recruiting)
- University Hospital Cologne — Cologne, Germany (Withdrawn)
- Internal Practice — Dornstadt, Germany (Recruiting)
- MVZ Düsseldorf — Düsseldorf, Germany (Withdrawn)
- University hospital Düsseldorf — Düsseldorf, Germany (Not_yet_recruiting)
- University Hospital Erlangen — Erlangen, Germany (Recruiting)
- St. Josef- Hospital Kupferdreh — Essen, Germany (Recruiting)
- University Hospital Essen — Essen, Germany (Not_yet_recruiting)
- University Hospital J.W. Goethe- Universität — Frankfurt am Main, Germany (Recruiting)
- Internal Practice — Frankfurt, Germany (Withdrawn)
- University Hospital Freiburg — Freiburg, Germany (Recruiting)
- University Hospital Gießen — Gießen, Germany (Recruiting)
- Gastroenerological-Oncological Practice — Halle, Germany (Recruiting)
- University Hospital Halle — Halle, Germany (Recruiting)
- Liver Center Hamburg - Asklepios Clinic St. Georg — Hamburg, Germany (Withdrawn)
- Internal Practice — Hameln, Germany (Withdrawn)
- Mhh — Hannover, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
- Gastroenerological Practice — Herne, Germany (Recruiting)
- University hospital Saarland — Homburg, Germany (Recruiting)
- University Hospital Jena — Jena, Germany (Recruiting)
- Gastroenerological Practice — Kassel, Germany (Withdrawn)
- Center for Gastroenterology and Hepatology Kiel — Kiel, Germany (Recruiting)
- University Hospital Schleswig-Holstein Campus Kiel — Kiel, Germany (Recruiting)
- Eugastro - Gastroenerological Practice — Leipzig, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Germany (Recruiting)
- MVZ Leverkusen — Leverkusen, Germany (Recruiting)
- University hospital Schleswig-Holstein — Lübeck, Germany (Recruiting)
- Internal Practice Hepatology — Magdeburg, Germany (Recruiting)
- University hospital Magdeburg — Magdeburg, Germany (Recruiting)
- University Hospital Mainz — Mainz, Germany (Recruiting)
- University Hospital Mannheim — Mannheim, Germany (Recruiting)
- Hospital LMU — Munich, Germany (Recruiting)
- Liver Center Munich — Munich, Germany (Withdrawn)
- Technical University - Klinikum rechts der Isar — Munich, Germany (Recruiting)
- University Hospital Münster — Münster, Germany (Recruiting)
- Hospital Nuremberg — Nuremberg, Germany (Recruiting)
- Internal Practice — Potsdam, Germany (Recruiting)
- University Hospital Regensburg — Regensburg, Germany (Withdrawn)
- Internal Practice — Schwerin, Germany (Withdrawn)
- Diakonie-Klinikum Schwäbisch Hall — Schwäbisch Hall, Germany (Withdrawn)
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
- University Hospital Ulm — Ulm, Germany (Not_yet_recruiting)
- St. Josefs-Hospital — Wiesbaden, Germany (Recruiting)
Study contacts
- Principal investigator: Johannes Wiegand, Prof.Dr. — University of Leipzig
- Study coordinator: Thomas Berg, Prof.Dr.
- Email: thomas.berg@medizin.uni-leipzig.de
- Phone: +49 341 97 12 330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.