A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life (OCARELIFE)
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| ClinicalTrials.gov Identifier: NCT03703076 |
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Recruitment Status : Unknown
Verified October 2018 by SAMEY, Intercept Pharma France SAS.
Recruitment status was: Recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
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| Condition or disease |
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| Primary Biliary Cholangitis |
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 |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| 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) |
| Actual Study Start Date : | April 10, 2018 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2019 |
- Response to Ocaliva® after 12 months of treatment [ Time Frame: 12 month ]Response to Ocaliva® after 12 months of treatment as monotherapy or in combination, using the published Paris 2 response criteria
- Response rate using the Paris 2 criteria at the end of the study [ Time Frame: 18 month ]Response rate using the Paris 2 criteria at the end of the study, 18 month after treatment initiation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703076
| Contact: Francois BOER, MD | 07 62 69 31 02 ext +33 | francois.boer@interceptpharma.com | |
| Contact: Benedicte SAMEY | 06 87 97 14 27 ext +33 | bsamey@axonal.com |
| France | |
| Chu Grenoble | Recruiting |
| Grenoble, France, 38700 | |
| Contact: Vincent LEROY, MD 0476765450 ext +33 vleroy@chu-grenoble.fr | |
| Contact: Laure Bordy lbordy@chu-grenoble.fr | |
| Hopital Saint Antoine | Recruiting |
| Paris, France, 75571 | |
| Contact: Christophe Corpechot, MD 01 49 28 28 36 ext +33 christophe.corpechot@aphp.fr | |
| Responsible Party: | SAMEY, CRO Project manager, Intercept Pharma France SAS |
| ClinicalTrials.gov Identifier: | NCT03703076 |
| Other Study ID Numbers: |
2018-A00075-50 |
| First Posted: | October 11, 2018 Key Record Dates |
| Last Update Posted: | October 11, 2018 |
| Last Verified: | October 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cholangitis Liver Cirrhosis, Biliary Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Cholestasis, Intrahepatic |
Cholestasis Liver Diseases Liver Cirrhosis Fibrosis Pathologic Processes |