A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life
OCARELIFE
1 other identifier
observational
150
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2018
CompletedFirst Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedOctober 11, 2018
October 1, 2018
12 months
October 9, 2018
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Response rate using the Paris 2 criteria at the end of the study
18 month
Eligibility Criteria
1\. Patients with PBC treated between October 1st, 2016 and December 31, 2017 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).
You may qualify if:
- 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)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SAMEYlead
- Axonal-Biostatemcollaborator
Study Sites (2)
Chu Grenoble
Grenoble, 38700, France
Hopital Saint Antoine
Paris, 75571, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- CRO Project manager
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 11, 2018
Study Start
April 10, 2018
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
October 11, 2018
Record last verified: 2018-10