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Elafibranor for Primary Biliary Cholangitis (ELFIDENCE Trial)

Phase 3

Recruiting

Research Sponsored by Ipsen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants must be ≥18 years of age at the time of signing the informed consent.

Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until 4 weeks after the end of treatment (maximum duration of 7 years)

Awards & highlights

ELFIDENCE Trial Summary

This trial will study if elafibranor can prevent the progression of PBC, a chronic disease that affects the bile ducts in the liver, leading to scarring & other symptoms. Participants will receive elafibranor or placebo over 7 years.

Who is the study for?

Adults over 18 with Primary Biliary Cholangitis (PBC) who haven't responded well to or can't tolerate the standard treatment, UDCA. They should be stable on any itch-management meds for at least 3 months and not have other significant health issues that could affect their participation. People with a history of certain liver diseases, substance abuse, cancer within the last five years, or specific medical conditions are excluded.Check my eligibility

What is being tested?

The trial is testing Elafibranor against a placebo in patients with PBC who don’t respond to UDCA. It aims to see if Elafibranor can prevent disease worsening better than a dummy pill over up to seven years while also monitoring long-term safety and effects on symptoms like itching and fatigue.See study design

What are the potential side effects?

While specific side effects for Elafibranor aren't listed here, common ones in trials may include digestive discomfort, potential liver enzyme changes, fatigue, headache, skin reactions or itching. The study will closely monitor participants for any adverse reactions throughout its duration.

ELFIDENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with primary biliary cholangitis.

ELFIDENCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until 4 weeks after the end of treatment (maximum duration of 7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until 4 weeks after the end of treatment (maximum duration of 7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until 4 weeks after the end of treatment (maximum duration of 7 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

Event-free survival

Secondary outcome measures

Apparent clearance of drug from plasma (CL)

Apparent volume of distribution (VZ)

Area under the plasma concentration-time curve from time 0 to 24 hours: AUC0-24

+52 more

ELFIDENCE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Elafibranor 80 mgExperimental Treatment1 Intervention

Participants will take 1 tablet of elafibranor 80 mg per day orally before breakfast with a glass of water at approximately the same time each morning.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take 1 placebo tablet per day orally (matching the 80 mg elafibranor sized tablet) before breakfast with a glass of water at approximately the same time each morning.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elafibranor

2022

Completed Phase 1

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

IpsenLead Sponsor

346 Previous Clinical Trials

72,850 Total Patients Enrolled

Ipsen Medical DirectorStudy DirectorIpsen

258 Previous Clinical Trials

54,839 Total Patients Enrolled

Frequently Asked Questions

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

Has Elafibranor 80 mg received the necessary clearance from the FDA?

"Given the presence of efficacy data and multiple safety studies, Elafibranor 80 mg is rated at a 3 on our risk scale."

Answered by AI

What is the current recruitment quota of this clinical trial?

"Affirmative. Clinicaltrials.gov documents demonstrate that this clinical trial, originally posted on September 1st 2023, is actively recruiting volunteers. 450 individuals must be recruited from 2 locations to complete the study."

Answered by AI

Are there vacancies for volunteers in this experiment?

"As indicated on clinicaltrials.gov, this medical investigation is actively recruiting patients for participation. The original posting date was September 1st 2023 and the most recent update to the listing occurred on September 12th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis

2023. "A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016842.

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