Informations générales (source: ClinicalTrials.gov)
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) (OCARELIFE)
Observational
SAMEY (Voir sur ClinicalTrials)
avril 2018
avril 2019
29 juin 2024
Post-authorisation non-interventional observational study of patients with Primary
Biliary Cholangitis who started Ocaliva® treatment between October 1st, 2016 and December
31, 2017.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint Antoine | Christophe Corpechot, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Grenoble - 38700 - Grenoble - France | Vincent LEROY, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.