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

Primary Biliary Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846896
• Other study ID #: SwissPBC - SASL36
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 31, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2017
• Source: Fondazione Epatocentro Ticino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PBC patients living in Switzerland

Exclusion Criteria:

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Locations

Country	Name	City	State
Switzerland	Fondazione Epatocentro Ticino	Lugano

Sponsors (4)

Lead Sponsor	Collaborator
Benedetta Terziroli, MD	Fondazione Epatocentro Ticino, Intercept Pharmaceuticals, Vifor Pharma

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of PBC in Switzerland		from 1.1.2005 until 31.12.2015