Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
NCT ID: NCT04076527
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2019-09-19
2024-03-31
Brief Summary
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Detailed Description
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Due to the low prevalence and the slowly progressive course of the disease it is very difficult to investigate the prognosis of subgroups of PBC patients or to evaluate the effectivness of therapeutic interventions on clinical outcomes. Therefore, several national or international registries (UK-PBC Consortium or the Global PBC Study Group) were founded to better characterize the clinical course of PBC patients.
Since in Germany a registry for PBC does not exist, the German PBC Cohort is being implemented as observational study to collect data on treatment progress and success in clinical routine that reflects real world conditions in Germany as closely as possible. The effectiveness and safety/tolerability of PBC treatment options (UDCA as standard therapy and second-line treatment options like OCALIVA in case of inadequate UDCA treatment response) will be evaluated.
In approximatly 40 sites in Germany routine data is collected. There are no specifications for the diagnosis, therapy and monitoring of the PBC patients. The documentation of the routine data is carried out alongside with guideline recommended treatment intervals of the patients.
Furthermore, a critical criterion for the German PBC Cohort study is the involvement of a sufficient number of gastroenterology specialized practices and outpatient clinics that have consciously not been selected based on the strict specifications of a clinical trial and which provide routine treatment for PBC patients. In addition, patient access is designed to be open. Data will be collected on patient groups that represent a majority of the PBC patients in Germany, but who are not being investigated in clinical trials.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 - Incomplete Responder
1. Primary Incomplete Responder: PBC patients demonstrating an insufficient response to the standard therapy with ursodeoxycholic acid (UDCA) after a minimum of 12 months of treatment (Paris II criteria).
2. Secondary Incomplete Responder: PBC patients demonstrating a satisfactory initial response to UDCA after a minimum of 12 months of treatment (Paris II criteria) followed by a re-increase of ALP ≥1.5 ULN, or AST ≥1.5 ULN, or bilirubin \>1 mg/dl at any later time point during continuous UDCA-treatment.
UDCA
Routine data is collected for UDCA therapy.
Ocaliva
Routine data is collected for OCA therapy.
Group 2 - Responder
PBC patients demonstrating a satisfactory initial and contin-ued response to UDCA after a minimum of 12 months of treatment (Paris II criteria) without a re-increase of ALP ≥1.5 ULN, or AST ≥1.5 ULN, or bilirubin \>1 mg/dl at any later time point during continuous UDCA-treatment.
UDCA
Routine data is collected for UDCA therapy.
Group 3
Patients newly diagnosed for PBC receiving an approved PBC therapy for the first time. Patients are considered to be newly diagnosed if the initial diagnosis took place no later than six months prior to inclusion into the study.
UDCA
Routine data is collected for UDCA therapy.
Ocaliva
Routine data is collected for OCA therapy.
Interventions
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UDCA
Routine data is collected for UDCA therapy.
Ocaliva
Routine data is collected for OCA therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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RWTH Aachen University
OTHER
Zentrum für Klinische Studien Leipzig
OTHER
Intercept Pharma Europe Limited (IPEL)
UNKNOWN
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
University Hospital Erlangen
OTHER
Medical care center for Gastroenterology, Berlin
UNKNOWN
Institute for Interdisciplinary Medicine, Hamburg
UNKNOWN
Leberhilfe Projekt gUG, Cologne
UNKNOWN
Hannover Medical School
OTHER
University of Leipzig
OTHER
Responsible Party
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Thomas Berg
Prof. Dr. Thomas Berg
Principal Investigators
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Thomas Berg, Prof.Dr.
Role: STUDY_CHAIR
University of Leipzig
Johannes Wiegand, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Leipzig
Christian Trautwein, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
RWTH Aachen University
Locations
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University Hospital Aachen
Aachen, , Germany
Charité - Campus Benjamin Franklin
Berlin, , Germany
Charité-Campus Virchow-Klinikum
Berlin, , Germany
Internal Practice
Berlin, , Germany
Liver Center Checkpoint
Berlin, , Germany
MVZ Gastroenterology
Berlin, , Germany
Hospital Chemnitz
Chemnitz, , Germany
University Hospital Cologne
Cologne, , Germany
Internal Practice
Dornstadt, , Germany
MVZ Düsseldorf
Düsseldorf, , Germany
University hospital Düsseldorf
Düsseldorf, , Germany
University Hospital Erlangen
Erlangen, , Germany
St. Josef- Hospital Kupferdreh
Essen, , Germany
University Hospital Essen
Essen, , Germany
Internal Practice
Frankfurt, , Germany
University Hospital J.W. Goethe- Universität
Frankfurt am Main, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
University Hospital Gießen
Giessen, , Germany
Gastroenerological-Oncological Practice
Halle, , Germany
University Hospital Halle
Halle, , Germany
Liver Center Hamburg - Asklepios Clinic St. Georg
Hamburg, , Germany
Internal Practice
Hamelin, , Germany
MHH
Hanover, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Gastroenerological Practice
Herne, , Germany
University hospital Saarland
Homburg, , Germany
University Hospital Jena
Jena, , Germany
Gastroenerological Practice
Kassel, , Germany
Center for Gastroenterology and Hepatology Kiel
Kiel, , Germany
University Hospital Schleswig-Holstein Campus Kiel
Kiel, , Germany
Eugastro - Gastroenerological Practice
Leipzig, , Germany
University Hospital Leipzig
Leipzig, , Germany
MVZ Leverkusen
Leverkusen, , Germany
University hospital Schleswig-Holstein
Lübeck, , Germany
Internal Practice Hepatology
Magdeburg, , Germany
University hospital Magdeburg
Magdeburg, , Germany
University Hospital Mainz
Mainz, , Germany
University Hospital Mannheim
Mannheim, , Germany
Hospital LMU
Munich, , Germany
Liver Center Munich
Munich, , Germany
Technical University - Klinikum rechts der Isar
Munich, , Germany
University Hospital Münster
Münster, , Germany
Hospital Nuremberg
Nuremberg, , Germany
Internal Practice
Potsdam, , Germany
University Hospital Regensburg
Regensburg, , Germany
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall, , Germany
Internal Practice
Schwerin, , Germany
University Hospital Tübingen
Tübingen, , Germany
University Hospital Ulm
Ulm, , Germany
St. Josefs-Hospital
Wiesbaden, , Germany
Countries
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Central Contacts
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Facility Contacts
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Christian Trautwein, Prof.Dr.
Role: primary
Marion Muche, Dr.
Role: primary
Tobias Müller, Dr.
Role: primary
Uwe Naumann, Dr.
Role: primary
Renate Heyne, Dr.
Role: primary
Wolf Peter Hofmann, Prof. Dr.
Role: primary
Ulrich Stölzel, Prof. Dr.
Role: primary
Nektarios Dikopoulos, Prof. Dr.
Role: primary
Hans Bock, Prof.
Role: primary
Andreas Kremer, Dr. Dr.
Role: primary
Susanne Beckebaum, Prof. Dr.
Role: primary
Sandra Christoph, Dr
Role: primary
Stefan Zeuzem, Prof. Dr.
Role: primary
Christoph Neumann-Haefelin, Dr.
Role: primary
Elke Roeb, Prof. Dr.
Role: primary
Rüdiger Behrens, Dr
Role: primary
Greinert, Dr.
Role: primary
Heike Bantel, Prof. Dr.
Role: primary
Theresa Hippchen, Dr.
Role: primary
Matthias Hinz, Dr.
Role: primary
Marcin Krawczyk, Prof. Dr.
Role: primary
Philipp Reuken, Dr.
Role: primary
Holger Hinrichsen, MD
Role: primary
Rainer Günther, Dr.
Role: primary
Ingolf Schiefke, Prof.
Role: primary
Thomas Berg, Prof. Dr.
Role: primary
Johannes Wiegand, Prof.Dr.
Role: backup
Karl- Georg Simon, Dr.
Role: primary
Henrike Dobbermann, Dr.
Role: primary
Kerstin Stein, Dr.
Role: primary
Verena Keitel-Anselmino, Prof. Dr.
Role: primary
Jörn Schattenberg, PD Dr
Role: primary
Andreas Teufel, Prof.Dr.Dr.
Role: primary
Gerald Denk, PD Dr
Role: primary
Ursula Tanase, Dr.
Role: primary
Hauke Heinzow, Prof. Dr.
Role: primary
Andreas Weber, Dr.
Role: primary
Harald Grümmer, Dr.
Role: primary
Christoph Berg, Prof. Dr.
Role: primary
Eugen Zizer, Dr.
Role: primary
Christoph Sarrazin, Prof. Dr.
Role: primary
Other Identifiers
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2.0
Identifier Type: -
Identifier Source: org_study_id
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