NCT03146910

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2017Dec 2030

Study Start

First participant enrolled

February 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

13.9 years

First QC Date

May 8, 2017

Last Update Submit

August 13, 2025

Conditions

Keywords

PBCPrimary Biliary CholangitisCohortAILD

Outcome Measures

Primary Outcomes (5)

  • Disease course

    Observing disease course

    3 years

  • Disease features

    Observing disease features in Swiss population and see if they are similar to other countries'

    3 years

  • Response to treatment

    Observing response to treatment

    3 years

  • Overall survival

    Observing overall survival

    3 years

  • Transplantation-free survival rate

    Observing transplantation-free survival rate

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Fondazione Epatocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Gastroenterologie und Hepatologie, Clarunis - Universitäres Bauchzentrum Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital

Bern, 3010, Switzerland

RECRUITING

Spital Bülach

Bülach, 8180, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève, Service de Gastroentérologie & Hépatologie, Département des Spécialités

Geneva, 1205, Switzerland

RECRUITING

CHUV: Centre hospitalier universitaire vaudois

Lausanne, 1005, Switzerland

RECRUITING

Kantonsspital Baselland

Liestal, 4410, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

EOC Ospedale Regionale di Lugano - Italiano

Lugano, 6900, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8400, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Serum (BD Vacutainer® SST II Advance) 2. RNA (PAXgene™ Blood RNA tube- 762165)

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Andreas Cerny, Prof. Dr. med

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

February 15, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations