Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016842
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-08-22
Brief Title:
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Phase III Randomised Parallel-Group Double-Blind Placebo-Controlled Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis PBC
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:
ELFIDENCE
Brief Summary:
The participants of this study will have confirmed Primary Biliary Cholangitis PBC and cirrhosis scarring of the liver
PBC is a slowly progressive disease characterised by damage to the bile ducts in the liver leading to a build-up of bile acids which causes further damage
The liver damage in PBC may lead to cirrhosis PBC may also be associated with multiple symptoms Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done
This study will compare a daily dose of elafibranor the study drug to a daily dose of placebo a dummy treatment and will last up to 35 years for each participant
The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening including progression of disease leading to liver transplant or death
This study will also study the safety of long-term treatment with elafibranor as well as the impact on symptoms such as itching and tiredness
PBC is a slowly progressive disease characterised by damage to the bile ducts in the liver leading to a build-up of bile acids which causes further damage
The liver damage in PBC may lead to cirrhosis PBC may also be associated with multiple symptoms Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done
This study will compare a daily dose of elafibranor the study drug to a daily dose of placebo a dummy treatment and will last up to 35 years for each participant
The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening including progression of disease leading to liver transplant or death
This study will also study the safety of long-term treatment with elafibranor as well as the impact on symptoms such as itching and tiredness
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505251-43-00 | CTIS | Ipsen | None |