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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
Must not have
Clinically significant hepatic decompensation, including patients with cirrhosis/portal hypertension complications
Patients with previous exposure to elafibranor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at weeks 4, 13, 26, 39 and 52
Awards & highlights
Pivotal Trial

Summary

This trial is testing a drug called elafibranor on patients with Primary Biliary Cholangitis (PBC) who haven't responded to standard treatment. The goal is to see if elafibranor can lower a specific liver enzyme and improve symptoms. Initially, participants will receive different treatments, and later, all will receive elafibranor for an extended period. Elafibranor has shown promise in improving symptoms in previous trials.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious liver problems, including cirrhosis or issues due to high blood pressure in the liver.
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I have previously been treated with elafibranor.
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I haven't taken immune-suppressing or liver-affecting drugs in the last 3 months.
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I have a serious kidney condition.
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I do not have any untreated serious illnesses.
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My blood clotting time is longer due to liver issues.
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I have or had another liver condition.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at weeks 4, 13, 26, 39 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and at weeks 4, 13, 26, 39 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52
Secondary study objectives
Change From Baseline at Week 52 in Bile Acids and Biomarkers of Bile Acid Synthesis as Measured by 7 Alpha-hydroxy-4-cholesten-3-one (C4) at Week 52
Change From Baseline in 5-D Itch at Week 52
Change From Baseline in ALP at Weeks 4, 13, 26, 39 and 52
+43 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Elafibranor 80mg open labelExperimental Treatment1 Intervention
Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
Group II: Elafibranor 80mg double-blindExperimental Treatment1 Intervention
Study participants will take 1 tablet per day orally before breakfast with a glass of water each morning
Group III: PlaceboPlacebo Group1 Intervention
Study participants 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
351 Previous Clinical Trials
74,211 Total Patients Enrolled
GenfitLead Sponsor
19 Previous Clinical Trials
3,344 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
260 Previous Clinical Trials
56,097 Total Patients Enrolled
Carol Addy, MD, MMScStudy DirectorGenfit

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 double-blind, Elafibranor 80mg open label, Placebo
~31 spots leftby Dec 2025
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