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The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02846896
First Posted: July 27, 2016
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fondazione Epatocentro Ticino
Vifor Pharma
Intercept Pharmaceuticals
Information provided by (Responsible Party):
Benedetta Terziroli, MD, Fondazione Epatocentro Ticino
  Purpose
PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.

Condition
Primary Biliary Cirrhosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years
Official Title: The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland

Resource links provided by NLM:


Further study details as provided by Benedetta Terziroli, MD, Fondazione Epatocentro Ticino:

Primary Outcome Measures:
  • Prevalence of PBC in Switzerland [ Time Frame: from 1.1.2005 until 31.12.2015 ]

Enrollment: 501
Actual Study Start Date: December 2015
Study Completion Date: March 2017
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PBC patients living in Switzerland
Criteria

Inclusion Criteria:

  • PBC patients living in Switzerland

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846896


Locations
Switzerland
Fondazione Epatocentro Ticino
Lugano, Switzerland, 6900
Sponsors and Collaborators
Benedetta Terziroli, MD
Fondazione Epatocentro Ticino
Vifor Pharma
Intercept Pharmaceuticals
  More Information

Responsible Party: Benedetta Terziroli, MD, MD, Fondazione Epatocentro Ticino
ClinicalTrials.gov Identifier: NCT02846896     History of Changes
Other Study ID Numbers: SwissPBC - SASL36
First Submitted: July 25, 2016
First Posted: July 27, 2016
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases