Post-authorisation non-interventional observational study of patients with Primary Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December 31, 2017.
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 Type
OBSERVATIONAL
Enrollment
150
Chu Grenoble
Grenoble, France
RECRUITINGHopital Saint Antoine
Paris, France
RECRUITINGResponse to Ocaliva® after 12 months of treatment
Response to Ocaliva® after 12 months of treatment as monotherapy or in combination, using the published Paris 2 response criteria
Time frame: 12 month
Response rate using the Paris 2 criteria at the end of the study
Response rate using the Paris 2 criteria at the end of the study, 18 month after treatment initiation
Time frame: 18 month
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