PBCNCT03146910
Swiss Primary Biliary Cholangitis Cohort Study
An observational study of PBC and Primary Biliary Cholangitis, run by Fondazione Epatocentro Ticino at 13 sites in Switzerland.
Trial summary
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PBC, Primary Biliary Cholangitis
- How many people
- 500 participants
- Where
- 13 sitesSwitzerland
- Study dates
- 15 Feb 2017to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with Primary biliary cholangitis according to recognized criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases). Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included. Patients/subjects aged at least 18 years and living in Switzerland are included.
Who may be able to join
- diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).
- Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included
- Patients/subjects aged at least 18 years and living in Switzerland are included
Who cannot join
- N/A
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Switzerland13 sites, 13 recruiting
- Recruiting
Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel
Basel, 4031
Christine Bernsmeier, PD Dr. med. Dr. phil., +41 61 777 7400, Christine.Bernsmeier@clarunis.ch
- Recruiting
Inselspital
Bern, 3010
Guido Stirnimann, MD, +4131 632 09 00, Guido.Stirnimann@insel.ch
- Recruiting
Spital Bülach
Bülach, 8180
Stephan Böhm, Prof. Dr. med, +41 44 863 24 30, stephan.boehm@spitalbuelach.ch
- Recruiting
Kantonsspital Graubünden
Chur, 7000
Simon Brunner, Dr. med., +41 81 256 63 07, simon.brunner@ksgr.ch
- Recruiting
Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités
Geneva, 1205
Giulia Magini, Dr. med., +41 22 372 93 40, giulia.magini@hug.ch
- Recruiting
CHUV: Centre hospitalier universitaire vaudois
Lausanne, 1005
Montserrat Fraga Christinet, +41 21 314 04 33, montserrat.fraga@chuv.ch
- Recruiting
Kantonsspital Baselland
Liestal, 4410
Magdalena Filipowicz-Sinnreich, MD, +41 61 925 23 60, Magdalena.Filipowicz@ksbl.ch
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Andrea De Gottardi, Prof. Dr. med, +41 41 205 21 31, Andrea.DeGottardi@luks.ch
- Recruiting
Fondazione Epatocentro Ticino
Lugano, Canton Ticino, 6900
Andreas Cerny, Prof. Dr. med, +41919106570, andreas.cerny@hin.ch
- Recruiting
EOC Ospedale Regionale di Lugano - Italiano
Lugano, 6900
Benedetta Terziroli Beretta-Piccoli, MD, +41 91 811 7637, Benedetta.TerziroliBeretta-Piccoli@eoc.ch
- Recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9007
David Semela, MD, +4171 4941216, David.Semela@kssg.ch
- Recruiting
Kantonsspital Winterthur
Winterthur, 8400
Björn Becker, MD, +41 052 266 21 21, bjoern.becker@ksw.ch
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Andreas Kremer, Prof. Dr. med, +41 44 255 85 48, andreas.kremer@usz.ch
About this study
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.
Read the detailed description
Enrolment visit and one follow-up visit at least once a year are planned.
Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.
To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.
- Conditions
- PBC, Primary Biliary Cholangitis
- Keywords
- PBC, Primary Biliary Cholangitis, Cohort, AILD
- Medical subject headings
- Liver Cirrhosis, Biliary
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease course
Observing disease course
Measured: 3 years
Disease features
Observing disease features in Swiss population and see if they are similar to other countries'
Measured: 3 years
Response to treatment
Observing response to treatment
Measured: 3 years
Overall survival
Observing overall survival
Measured: 3 years
Transplantation-free survival rate
Observing transplantation-free survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start15 Feb 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fondazione Epatocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146910
- Sponsor's protocol ID
- SASL39 - Swiss PBC Cohort
- Status last verified
- Aug 2025
- First submitted
- 8 May 2017
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Primary Biliary Cholangitis Cohort Study
- ClinicalTrials.gov ID
- NCT03146910
- Acronym / sponsor ID
- SASL39 - Swiss PBC Cohort
- Conditions
- PBC, Primary Biliary Cholangitis
- Keywords
- PBC, Primary Biliary Cholangitis, Cohort, AILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fondazione Epatocentro TicinoUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 May 2017 (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.
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.
Detailed description
Enrolment visit and one follow-up visit at least once a year are planned.
Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.
To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Primary biliary cholangitis according to recognized criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases). Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included. Patients/subjects aged at least 18 years and living in Switzerland are included.
Key inclusion criteria (3 listed)
- diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).
- Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included
- Patients/subjects aged at least 18 years and living in Switzerland are included
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease course
Time frame: 3 years
Observing disease course
Disease features
Time frame: 3 years
Observing disease features in Swiss population and see if they are similar to other countries'
Response to treatment
Time frame: 3 years
Observing response to treatment
Overall survival
Time frame: 3 years
Observing overall survival
Transplantation-free survival rate
Time frame: 3 years
Observing transplantation-free survival rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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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.
13 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 Fondazione Epatocentro Ticino at 13 sites in Switzerland.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Cerny, Prof. Dr. med (+41919106570, andreas.cerny@hin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease course (time frame: 3 years). The study lists 5 primary outcomes in all. 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 17 Aug 2025.