Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447168
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-06-03
Brief Title:
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
Prospective Non-interventional Phase IV Multicentre Study to Assess the Effectiveness Safety and Tolerability of Elafibranor 80 mgDay in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELFINITY
Brief Summary:
This study will collect information from participants with Primary Biliary Cholangitis PBC as they use the drug elafibranor in real world setting
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged
The liver damage in PBC may lead to scarring cirrhosis PBC may also be associated with multiple symptoms Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done
In this study the main aim is to observe the effectiveness safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting The total study duration for each participants will be 24 months
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged
The liver damage in PBC may lead to scarring cirrhosis PBC may also be associated with multiple symptoms Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done
In this study the main aim is to observe the effectiveness safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting The total study duration for each participants will be 24 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None