PBCPBC-CohortNCT04076527
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
An observational study of PBC and Primary Biliary Cholangitis, run by University of Leipzig at 50 sites in Germany.
Trial 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 biliary cholangitis (PBC) in patients in Germany under routine treatment with approved drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PBC, Primary Biliary Cholangitis
- What is being tested?
- UDCA and Ocaliva
- How many people
- 1,200 participants
- Where
- 50 sitesGermany
- Study dates
- 19 Sep 2019to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will be recruited in gastroenterology specialized practices and outpatient clinics which provide routine treatment for PBC patients.
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- Current participation in a phase I to IV interventional clinical trial for PBC or participation in another PBC registry.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Germany50 sites, 40 recruiting
- Recruiting
University Hospital Aachen
Aachen
Christian Trautwein, Prof.Dr.
- Recruiting
Charité - Campus Benjamin Franklin
Berlin
Marion Muche, Dr.
- Recruiting
Charité-Campus Virchow-Klinikum
Berlin
Tobias Müller, Dr.
- Recruiting
Internal Practice
Berlin
Uwe Naumann, Dr.
- Not yet recruiting
Liver Center Checkpoint
Berlin
Renate Heyne, Dr.
- Recruiting
MVZ Gastroenterology
Berlin
Wolf Peter Hofmann, Prof. Dr.
- Recruiting
Hospital Chemnitz
Chemnitz
Ulrich Stölzel, Prof. Dr.
- Withdrawn
University Hospital Cologne
Cologne
- Recruiting
Internal Practice
Dornstadt
Nektarios Dikopoulos, Prof. Dr.
- Withdrawn
MVZ Düsseldorf
Düsseldorf
- Not yet recruiting
University hospital Düsseldorf
Düsseldorf
Hans Bock, Prof.
- Recruiting
University Hospital Erlangen
Erlangen
Andreas Kremer, Dr. Dr.
- Recruiting
St. Josef- Hospital Kupferdreh
Essen
Susanne Beckebaum, Prof. Dr.
- Not yet recruiting
University Hospital Essen
Essen
Sandra Christoph, Dr
- Withdrawn
Internal Practice
Frankfurt
- Recruiting
University Hospital J.W. Goethe- Universität
Frankfurt am Main
Stefan Zeuzem, Prof. Dr.
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau
Christoph Neumann-Haefelin, Dr.
- Recruiting
University Hospital Gießen
Giessen
Elke Roeb, Prof. Dr.
- Recruiting
Gastroenerological-Oncological Practice
Halle
Rüdiger Behrens, Dr
- Recruiting
University Hospital Halle
Halle
Greinert, Dr.
- Withdrawn
Liver Center Hamburg - Asklepios Clinic St. Georg
Hamburg
- Withdrawn
Internal Practice
Hamelin
- Recruiting
MHH
Hanover
Heike Bantel, Prof. Dr.
- Recruiting
University Hospital Heidelberg
Heidelberg
Theresa Hippchen, Dr.
- Recruiting
Gastroenerological Practice
Herne
Matthias Hinz, Dr.
- Recruiting
University hospital Saarland
Homburg
Marcin Krawczyk, Prof. Dr.
- Recruiting
University Hospital Jena
Jena
Philipp Reuken, Dr.
- Withdrawn
Gastroenerological Practice
Kassel
- Recruiting
Center for Gastroenterology and Hepatology Kiel
Kiel
Holger Hinrichsen, MD
- Recruiting
University Hospital Schleswig-Holstein Campus Kiel
Kiel
Rainer Günther, Dr.
- Recruiting
Eugastro - Gastroenerological Practice
Leipzig, 04129
Ingolf Schiefke, Prof.
- Recruiting
University Hospital Leipzig
Leipzig
Thomas Berg, Prof. Dr.
Johannes Wiegand, Prof.Dr.
- Recruiting
MVZ Leverkusen
Leverkusen
Karl- Georg Simon, Dr.
- Recruiting
University hospital Schleswig-Holstein
Lübeck
Henrike Dobbermann, Dr.
- Recruiting
Internal Practice Hepatology
Magdeburg
Kerstin Stein, Dr.
- Recruiting
University hospital Magdeburg
Magdeburg
Verena Keitel-Anselmino, Prof. Dr.
- Recruiting
University Hospital Mainz
Mainz
Jörn Schattenberg, PD Dr
- Recruiting
University Hospital Mannheim
Mannheim
Andreas Teufel, Prof.Dr.Dr.
- Recruiting
Hospital LMU
Munich
Gerald Denk, PD Dr
- Withdrawn
Liver Center Munich
Munich
- Recruiting
Technical University - Klinikum rechts der Isar
Munich
Ursula Tanase, Dr.
- Recruiting
University Hospital Münster
Münster
Hauke Heinzow, Prof. Dr.
- Recruiting
Hospital Nuremberg
Nuremberg
Andreas Weber, Dr.
- Recruiting
Internal Practice
Potsdam
Harald Grümmer, Dr.
- Withdrawn
University Hospital Regensburg
Regensburg
- Withdrawn
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall
- Withdrawn
Internal Practice
Schwerin
- Recruiting
University Hospital Tübingen
Tübingen
Christoph Berg, Prof. Dr.
- Not yet recruiting
University Hospital Ulm
Ulm
Eugen Zizer, Dr.
- Recruiting
St. Josefs-Hospital
Wiesbaden
Christoph Sarrazin, Prof. Dr.
About this study
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 biliary cholangitis (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.
Read the 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. Prognosis depends on the development of cirrhosis and its complications. Ursodeoxycholic acid (UDCA) has been established as standard therapy for PBC and improves patients' long-term outcome. However, UDCA is not a uniformly effective drug, and the prognosis of PBC patients insufficiently responding to treatment is markedly worse. For patients with suboptimal treatment response to UDCA obeticholic acid (OCA) as newly approved medication (OCALIVA®) is available as second line treatment.
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
- PBC, Primary Biliary Cholangitis
- Being tested
- UDCA, Ocaliva
- Keywords
- ursodeoxycholic acid, UDCA, obeticholic acid, OCALIVA, Cohort, observational study, Bezafibrat, Budesonide
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDCADrug
Also called ursodeoxycholic acid
Routine data is collected for UDCA therapy.
OcalivaDrug
Also called obeticholic acid
Routine data is collected for OCA therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: UDCA; Drug: Ocaliva | |
| 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. Receives: Drug: UDCA | |
| 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. Receives: Drug: UDCA; Drug: Ocaliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematic registry
A primary outcome measure is not applicable as usual, since this data acquisition is performed to built a newly developed systematic registry which serves to describe - for the first time in Germany - the characteristics and the recent state of usual clinical care of the respective population.
Within the 18 months of recruitment and 3 years of individual follow-up for every patient regular analyses will be performed and published, based on a statistical analysis plan which may be yearly updated on request to address the main questions of the responsible PBC consortium.
After the end of data acquisition hepatologic scientists may apply with detailed proposals to further use available data. A scientific consortium will than decided on further analyses of data.
Measured: from baseline to 36 months after baseline (observational period)
Secondary outcomes (7)
Comprehensive clinical characterization of German PBC patients
i.e. demographics, biochemical markers, ultrasound, transient elastography, stage of the disease
Measured: from baseline to 36 months after baseline
Characterization of PBC therapies
Characterization of UDCA as first line therapy and characterization of approved second-line treatment options such as OCALIVA.
Furthermore, safety data on the PBC medications used will be systematically gathered and reported on high-level aggregation with regard to any causality with PBC treatment per cohort. The respective results will be reviewed against the known safety profiles.
Measured: from baseline to 36 months after baseline
Treatment response to PBC therapies after 12 months and during longer courses of application
To evaluate the natural progression under PBC drug therapy with respect to response to treatment changes in laboratory results (as ratios of the upper/lower limits of normal or differences to BL values) and characteristics of liver function will be described, e.g.:
- frequency of hepatic decompensation (occurrence of variceal hemorrhage, ascites, encephalopathy, and/or hepatocellular carcinoma),
- frequency of liver transplants,
- frequency of deaths in total and from a liver-related cause, and
- details on further events of special interest, e.g. for the first time serum bilirubin > ULN and/or alkaline phosphatase > 1.5 ULN, or transient elastography > 9.6 kPa.
Measured: from baseline to 12 months after baseline and to 36 months after baseline
Application and analyses of existing prognostic PBC scores to provide information on patients' prognosis.
Details on typical therapeutic measures in treating PBC and patient compliance will be presented. This allows making a statement on quality of PBC treatment in Germany. Effectiveness will be assessed per cohort and compared between physicians' practices and hospital outpatient departments, aggregating data over all participating sites of the respective structure of health care. This refers to GLOBE score and/or Paris II criteria, frequency of hepatic decompensation or frequency of abnormal surrogate parameter (i.e. alkaline phosphatase, bilirubin, ALAT, ASAT or transient elastography). The respective results will be discussed against the results provided from clinical trials to verify everyday suitability of the different PBC therapies.
Measured: from baseline to 36 months after baseline
Concomitant Medications
Assessment of selected concomitant medications (e.g. symptomatic treatment of pru-ritus)
Measured: from baseline to 36 months after baseline
Concomitant Autoimmune Diseases
Assessment of selected concomitant autoimmune diseases (e.g. overlap syndrome with autoimmune hepatitis)
Measured: from baseline to 36 months after baseline
Concomitant Non-Autoimmune Diseases
Assessment of selected concomitant non-autoimmune diseases (i.e. cardiovascular disease, non-alcoholic fatty liver disease, metabolic syndrome, chronic kidney diseases)
Measured: from baseline to 36 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start19 Sep 2019
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- RWTH Aachen University, Zentrum für Klinische Studien Leipzig, Intercept Pharma Europe Limited (IPEL), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital Erlangen, Medical care center for Gastroenterology, Berlin, Institute for Interdisciplinary Medicine, Hamburg, Leberhilfe Projekt gUG, Cologne, Hannover Medical School
- Responsible party
- Principal investigator, Thomas Berg, University of Leipzig
- Investigators
- Thomas Berg, Prof.Dr., Study chair, University of LeipzigJohannes Wiegand, Prof.Dr., Principal investigator, University of LeipzigChristian Trautwein, Prof.Dr., Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076527
- Sponsor's protocol ID
- 2.0
- Acronym
- PBC-Cohort
- Status last verified
- Jun 2023
- First submitted
- 29 Aug 2019
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT04076527
- Acronym / sponsor ID
- PBC-Cohort / 2.0
- Conditions
- PBC, Primary Biliary Cholangitis
- Keywords
- ursodeoxycholic acid, UDCA, obeticholic acid, OCALIVA, Cohort, observational study, Bezafibrat, Budesonide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- RWTH Aachen University, Zentrum für Klinische Studien Leipzig, Intercept Pharma Europe Limited (IPEL), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University Hospital Erlangen, Medical care center for Gastroenterology, Berlin, Institute for Interdisciplinary Medicine, Hamburg, Leberhilfe Projekt gUG, Cologne, Hannover Medical School
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 biliary cholangitis (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.
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. Prognosis depends on the development of cirrhosis and its complications. Ursodeoxycholic acid (UDCA) has been established as standard therapy for PBC and improves patients' long-term outcome. However, UDCA is not a uniformly effective drug, and the prognosis of PBC patients insufficiently responding to treatment is markedly worse. For patients with suboptimal treatment response to UDCA obeticholic acid (OCA) as newly approved medication (OCALIVA®) is available as second line treatment.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Incomplete Responder | – | Drug: UDCA, Drug: Ocaliva1. 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. |
| Group 2 - Responder | – | Drug: UDCAPBC 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. |
| Group 3 | – | Drug: UDCA, Drug: OcalivaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited in gastroenterology specialized practices and outpatient clinics which provide routine treatment for PBC patients.
Key inclusion criteria (17 listed)
- 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:
- 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:
- Patients must meet criteria of one of the cohorts (group 1/2/3) within this NIS according to design
Key exclusion criteria (1 listed)
- Current participation in a phase I to IV interventional clinical trial for PBC or participation in another PBC registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UDCAAlso: ursodeoxycholic acidRoutine data is collected for UDCA therapy. | Drug | Group 1 - Incomplete Responder, Group 2 - Responder, Group 3 |
| OcalivaAlso: obeticholic acidRoutine data is collected for OCA therapy. | Drug | Group 1 - Incomplete Responder, Group 3 |
Primary outcome
Systematic registry
Time frame: from baseline to 36 months after baseline (observational period)
A primary outcome measure is not applicable as usual, since this data acquisition is performed to built a newly developed systematic registry which serves to describe - for the first time in Germany - the characteristics and the recent state of usual clinical care of the respective population. Within the 18 months of recruitment and 3 years of individual follow-up for every patient regular analyses will be performed and published, based on a statistical analysis plan which may be yearly updated on request to address the main questions of the responsible PBC consortium. After the end of data acquisition hepatologic scientists may apply with detailed proposals to further use available data. A scientific consortium will than decided on further analyses of data.
7 secondary outcomes
Comprehensive clinical characterization of German PBC patients
Time frame: from baseline to 36 months after baseline
Characterization of PBC therapies
Time frame: from baseline to 36 months after baseline
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
Application and analyses of existing prognostic PBC scores to provide information on patients' prognosis.
Time frame: from baseline to 36 months after baseline
Concomitant Medications
Time frame: from baseline to 36 months after baseline
Concomitant Autoimmune Diseases
Time frame: from baseline to 36 months after baseline
Concomitant Non-Autoimmune Diseases
Time frame: from baseline to 36 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Berg, Prof.Dr. study chair
University of Leipzig
Johannes Wiegand, Prof.Dr. principal investigator
University of Leipzig
Christian Trautwein, Prof.Dr. principal investigator
RWTH Aachen University
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PBC and Primary Biliary Cholangitis, run by University of Leipzig at 50 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Berg, Prof.Dr. (+49 341 97 12 330, thomas.berg@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systematic registry (time frame: from baseline to 36 months after baseline (observational period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.