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Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (ELATIVE)

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ClinicalTrials.gov Identifier: NCT04526665
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Genfit

Brief Summary:
The main objective of the study is to evaluate the effect of daily oral administration of 80mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with PBC and inadequate response or intolerance to Ursodeoxycholic Acid (UCDA)

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Elafibranor 80mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a double-blind (DB), randomized, placebo-controlled study followed by an open-label long term extension (LTE)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2028


Arm Intervention/treatment
Experimental: Elafibranor 80mg
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning
Drug: Elafibranor 80mg
Elafibranor 80mg for double blind period (52 to 104 weeks). After completion of the double blind period, participants will be offered the opportunity to enter an open label long term extension study for up to 5 years. Participants will continue the elafibranor dose received during the double blind period.

Placebo Comparator: Placebo
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning
Drug: Placebo
Placebo for double blind period (52 to 104 weeks). After completion of the double blind period, participants will be offered the opportunity to enter an open label long term extension study and to switch to elafibranor 80mg for up to 5 years.




Primary Outcome Measures :
  1. Effect of elafibranor (80 mg/day) on cholestasis [ Time Frame: From baseline to 52 weeks of treatment ]
    Response to treatment defined as Alkaline phosphatase (ALP) < 1.67 x Upper Limit Normal (ULN) and Total Bilirubin (TB) ≤ ULN and ALP decrease ≥ 15 percent


Secondary Outcome Measures :
  1. Response to treatment based on ALP normalization [ Time Frame: At week 52 ]
  2. Change in pruritis from baseline [ Time Frame: Over 52 weeks of treatment ]
    Based on PBC Worst Itch Numeric Rating Scale (NRS) score measuring itch over the past 24 hours from 0 (no itch) to 10 (worst itch imaginable)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females age of 18 to 75 years (inclusive)
  • Definite or probable PBC diagnosis
  • ALP ≥ 1.67x upper limit of normal (ULN)
  • Total bilirubin (TB) ≤ 2x ULN
  • UDCA for at least 12 months (stable dose ≥ 3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for ≥ 3 months) prior to screening (per country standard-of-care dosing)
  • Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake

Exclusion Criteria:

  • History or presence of other concomitant liver disease
  • Clinically significant hepatic decompensation, including patients with cirrhosis/portal hypertension complications
  • Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers
  • Patient has a positive test for Human Immunodeficiency Virus (HIV)
  • Evidence of any other unstable or untreated clinically significant disease
  • History of alcohol abuse
  • For female patients: known pregnancy or lactating
  • Use of fibrates and glitazones within 2 months prior to screening
  • Use of azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids; potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin) within 3 months prior to screening
  • Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening
  • For patients with previous exposure to obeticholic acid (OCA), OCA should be discontinued 3 months prior to screening
  • Patients who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening.
  • Patients with previous exposure to elafibranor
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5x ULN
  • Albumin < 3.0 g/dL
  • PBC Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin < LLN)
  • International normalized ratio (INR) > 1.3 due to altered hepatic function
  • Creatine phosphokinase CPK > 2X ULN
  • Serum creatinine > 1.5 mg/dL
  • Significant renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526665


Contacts
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Contact: Genfit +33(0)320164000 clinicaltrial@genfit.com

Locations
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Sponsors and Collaborators
Genfit
Investigators
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Study Director: Carol Addy, MD, MMSc Genfit
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Responsible Party: Genfit
ClinicalTrials.gov Identifier: NCT04526665    
Other Study ID Numbers: GFT505B-319-1
2019-004941-34 ( EudraCT Number )
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genfit:
Primary Biliary Cholangitis
PBC
Elafibranor
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis