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A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life — OCARELIFE  

Primary Biliary Cholangitis Clinical Trial

Official title:
A Post-Authorisation Non-Interventional Observational, Multi-Site Study of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life (OCARELIFE)

Clinical Trial Summary

Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.

Clinical Trial Description

This is a non-interventional, multi-site, ambispective, national follow-up study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017. This represents approximately 150 patients to date, who are therefore the first patients to have received treatment with Ocaliva® in France outside of pre-approval clinical trials.

All patients who received treatment within the context of the ATU (conditional marketing authorization in France) or after EU marketing authorization approval for the product will be followed up for 18 months (this follow-up will be partly retrospective and partly prospective). The study therefore involves retrospective recruitment with retrospective and prospective data collection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03703076
Study type Observational
Source Intercept Pharma France SAS
Contact Francois BOER, MD
Phone 07 62 69 31 02
Email francois.boer@interceptpharma.com
Status Recruiting
Phase
Start date April 10, 2018
Completion date April 2019
View Details
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