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PPAR agonist

Elafibranor for Primary Biliary Cholangitis (ELATIVE Trial)

Phase 3
Waitlist Available
Research Sponsored by Ipsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Definite or probable PBC diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 4, 13, 26, 39 and week 52 and up to a maximum of 6 years
Awards & highlights

ELATIVE Trial Summary

This trial is testing a new drug to see if it can help people with PBC who can't take or haven't responded well to UCDA.

Who is the study for?
This trial is for adults aged 18-75 with Primary Biliary Cholangitis (PBC) who haven't responded well to or can't tolerate Ursodeoxycholic Acid. They must have a certain level of ALP enzyme and be using effective contraception if applicable. Exclusions include HIV, pregnancy, alcohol abuse, previous Elafibranor use, certain liver conditions, high levels of liver enzymes or bilirubin, low albumin or abnormal blood clotting.Check my eligibility
What is being tested?
The study tests the effects of daily oral Elafibranor (80mg) versus placebo on bile flow impairment in PBC patients intolerant or unresponsive to standard treatment. Participants are randomly assigned in a 2:1 ratio to receive either Elafibranor or placebo.See study design
What are the potential side effects?
While specific side effects for Elafibranor aren't listed here, common side effects for drugs treating PBC may include itching, fatigue, abdominal pain and discomfort; however individual experiences with medications can vary.

ELATIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with primary biliary cholangitis.

ELATIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 4, 13, 26, 39 and week 52 and up to a maximum of 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4, 13, 26, 39 and week 52 and up to a maximum of 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with response to treatment measured by the combination levels of Alkaline Phosphate Levels (ALP) and Total Bilirubin (TB)
Secondary outcome measures
Area Under Curve steady state (AUCss) of study drug
Change from baseline in 5D-Itch
Change from baseline in ALP levels
+57 more

ELATIVE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Elafibranor 80mgExperimental Treatment1 Intervention
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning
Group II: PlaceboPlacebo Group1 Intervention
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor
345 Previous Clinical Trials
73,067 Total Patients Enrolled
GenfitLead Sponsor
19 Previous Clinical Trials
3,344 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
54,984 Total Patients Enrolled

Media Library

Elafibranor 80mg (PPAR agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04526665 — Phase 3
Elafibranor 80mg (PPAR agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04526665 — Phase 3
Primary Biliary Cirrhosis Clinical Trial 2023: Elafibranor 80mg Highlights & Side Effects. Trial Name: NCT04526665 — Phase 3
Primary Biliary Cirrhosis Research Study Groups: Elafibranor 80mg, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study still have room for willing participants?

"This particular study is not recruiting patients at the moment. If you're interested in other studies, there are 49 clinical trials for patients with liver cirrhosis and biliary, as well as 1 trial for Elafibranor 80mg."

Answered by AI

What are some of the dangers Elafibranor 80mg poses to patients?

"Elafibranor 80mg's safety is rated highly by our team because it has progressed to Phase 3 trials. This signifies that, while more research is needed, there is evidence suggesting its efficacy and that it is safe."

Answered by AI

Are there other instances where Elafibranor 80mg has been trialled?

"Elafibranor 80mg was first trialled at Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital in 2020. Since the initial study, there have been 18,245 completed clinical trials worldwide. There is currently 1 live study, with many of the trial sites based in Columbus, Ohio."

Answered by AI

Are there other similar studies to this one?

"As of right now, there is a single active clinical trial for Elafibranor 80mg in 54 cities across 14 countries. The earliest study dates back to 2020 and was sponsored by Genfit. It involved 150 patients and completed Phase 3 drug approval. Since then, there have been a total of 18,245 studies conducted."

Answered by AI

Does this research study include patients that are seniors?

"The age limit for this clinical trial is 75 years old. All patients that wish to enroll must be over the age of 18."

Answered by AI

Are there specific inclusion criteria for participants in this trial?

"This clinical research is looking for 150 individuals with biliary cirrhosis aged between 18-75. All that meet the following requirements: have been taking UDCA for at least 12 months prior to screening (or if unable to tolerate UDCA treatment, no UDCA for 3 months or more prior to screening), per country standard-of-care dosing."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Texas Digestive Disease Consultants dba GI Alliance
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
2020. "Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526665.
All > Liver Cirrhosis > Primary Biliary Cirrhosis
~36 spots leftby Apr 2025
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