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

Primary Biliary Cholangitis Clinical Trial

— OCARELIFE  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03703076
• Other study ID #: 2018-A00075-50
• Status: Recruiting
• Start date: April 10, 2018
• Est. completion date: April 2019

Study information

• Verified date: October 2018
• Source: Intercept Pharma France SAS
• Contact: Francois BOER, MD
• Phone: 07 62 69 31 02
• Email: francois.boer[@]interceptpharma.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with PBC treated with Ocaliva® 5 mg or 10 mg according to the terms of Ocaliva® approved SmPC: in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA (over the age of 18 years at the time of treatment introduction).

• Patients with PBC with a suboptimal response to UDCA who received at least one dose of Ocaliva®.

• Patients with or without an overlap syndrome (Nguyen-Khac E, 2004)

• Prior to any follow-up and inclusion in this cohort, the attending physician must give the patient or his or her legal representative or designated healthcare proxy information on the drug, a side effect report and notice of his or her inclusion in the cohort (patient information sheet in writing).

• The patient (or his or her legal representative or designated healthcare proxy) must have read the information sheet and agreed verbally to take part, and must show the sheet to any doctor who is consulted.

Exclusion Criteria:

• Diseases triggering a non-hepatic elevation of alkaline phosphatases (ALP) (for example Paget's disease or fractures within the previous three months).

• Participation in another investigational study on a product, biological material or medical device within the 30 days prior to selection.

• Inability to comply with the study follow-up procedures.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble
France	Hopital Saint Antoine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
SAMEY	AXONAL-BIOSTATEM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response 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	12 month
Secondary	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	18 month