Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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20 June 2023 |
Main ID: |
NCT04076527 |
Date of registration:
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29/08/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
PBC-Cohort |
Scientific title:
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Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis |
Date of first enrolment:
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September 19, 2019 |
Target sample size:
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1200 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT04076527 |
Study type:
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Observational |
Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Thomas Berg, Prof.Dr. |
Address:
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Telephone:
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+49 341 97 12 330 |
Email:
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thomas.berg@medizin.uni-leipzig.de |
Affiliation:
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Name:
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Johannes Wiegand, Prof.Dr. |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Leipzig |
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Name:
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Christian Trautwein, Prof.Dr. |
Address:
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Telephone:
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Email:
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Affiliation:
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RWTH Aachen University |
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Name:
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Thomas Berg, Prof.Dr. |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Leipzig |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cholangitis
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PBC
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Intervention(s)
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Drug: UDCA
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Drug: Ocaliva
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Primary Outcome(s)
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Systematic registry
[Time Frame: from baseline to 36 months after baseline (observational period)]
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Secondary Outcome(s)
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Concomitant Non-Autoimmune Diseases
[Time Frame: from baseline to 36 months after baseline]
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Characterization of PBC therapies
[Time Frame: from baseline to 36 months after baseline]
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Concomitant Autoimmune Diseases
[Time Frame: from baseline to 36 months after baseline]
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Application and analyses of existing prognostic PBC scores to provide information on patients' prognosis.
[Time Frame: from baseline to 36 months after baseline]
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Comprehensive clinical characterization of German PBC patients
[Time Frame: from baseline to 36 months after baseline]
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Concomitant Medications
[Time Frame: from baseline to 36 months after baseline]
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Treatment response to PBC therapies after 12 months and during longer courses of application
[Time Frame: from baseline to 12 months after baseline and to 36 months after baseline]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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