Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383403
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Phase IIIb Randomised Parallel-Group Double-Blind Placebo-Controlled Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis PBC and Inadequate Response or Intolerance to Ursodeoxycholic Acid
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:
ELSPIRE
Brief Summary:
The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid UDCA which is a medication used in the management and treatment of cholestatic liver disease
Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring cirrhosis PBC may also be associated with multiple symptoms
Many patients with PBC may require a 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
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value High ALP levels in the blood can indicate liver disease
There will be three periods in this study A screening period up to 8 weeks to assess whether the participant can take part a treatment period up to 52 weeks where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo and a follow-up period 4 weeks where participants health will be monitored
Participants will be twice as likely to receive elafibranor than placebo 21 ratio
Participants will undergo blood sampling urine collections physical examinations clinical evaluations electrocardiograms ECG recording of the electrical activity of heart ultrasound examinations a noninvasive test that passes a probe over skin to look at the bladder urinary tract and liver and Fibroscan examinations a noninvasive test that passes a probe on skin to measure stiffness of the liver
They will also be asked to fill in questionnaires Each participant will be in this study for up to 64 weeks 15 months
Primary biliary cholangitis is a slowly progressive disease characterised by damage of 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 scarring cirrhosis PBC may also be associated with multiple symptoms
Many patients with PBC may require a 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
The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value High ALP levels in the blood can indicate liver disease
There will be three periods in this study A screening period up to 8 weeks to assess whether the participant can take part a treatment period up to 52 weeks where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo and a follow-up period 4 weeks where participants health will be monitored
Participants will be twice as likely to receive elafibranor than placebo 21 ratio
Participants will undergo blood sampling urine collections physical examinations clinical evaluations electrocardiograms ECG recording of the electrical activity of heart ultrasound examinations a noninvasive test that passes a probe over skin to look at the bladder urinary tract and liver and Fibroscan examinations a noninvasive test that passes a probe on skin to measure stiffness of the liver
They will also be asked to fill in questionnaires Each participant will be in this study for up to 64 weeks 15 months
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 |
|---|---|---|---|
| 2024-510695-20-00 | CTIS | None | None |