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Trial record 2 of 10 for:    elafibranor

Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

This study is currently recruiting participants.
Verified November 2017 by Genfit
Sponsor:
ClinicalTrials.gov Identifier:
NCT03124108
First Posted: April 21, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Genfit
  Purpose
The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

Condition Intervention Phase
Primary Biliary Cholangitis (PBC) Drug: Elafibranor 80 mg Drug: Elafibranor 120 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

Resource links provided by NLM:


Further study details as provided by Genfit:

Primary Outcome Measures:
  • Change in serum alkaline phosphatase (ALP) [ Time Frame: Measurements at Baseline and 12 weeks ]
    To evaluate the efficacy of elafibranor 80 and 120 mg with respect to relative change from baseline in serum ALP levels compared to placebo


Secondary Outcome Measures:
  • Composite endpoint composed of ALP and total bilirubin [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups, with response defined as ALP less than 1.67 times ULN and total bilirubin within normal limits and ALP reduction > 15%

  • Composite endpoint composed of ALP and total bilirubin [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups, with response defined as ALP less than 2 times ULN and total bilirubin within normal limits and ALP reduction > 40%

  • Paris I PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Paris I PBC risk score

  • Paris II PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Paris II PBC risk score

  • Toronto I PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Toronto I PBC risk score

  • Toronto II PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to Toronto II PBC risk score

  • UK PBC risk score [ Time Frame: Measurements at 12 weeks ]
    To assess response rate in elafibranor 80 mg and 120 mg and placebo groups according to UK PBC risk score

  • Normalization of ALP levels [ Time Frame: Measurements at 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on normalization of ALP

  • Liver enzymes [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on liver enzymes and liver markers

  • Fibrosis markers [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on fibrosis markers

  • Lipid parameters [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on lipid parameters

  • Inflammatory markers [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the response to elafibranor 80 mg and 120 mg versus placebo treatment on inflammatory markers

  • Pruritis score [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the efficacy of elafibranor 80 and 120 mg versus placebo treatment with respect to the change from baseline in pruritus (through 5D-itch scale and visual analogue score VAS)

  • Quality of Life parameters [ Time Frame: Measurements at Baseline and 12 weeks ]
    To assess the efficacy of elafibranor 80 and 120 mg versus placebo treatment with respect to the change from baseline in Quality of Life (using PBC 40 questionnaire)

  • Assess the tolerability and safety of elafibranor 80 mg and 120 mg in patients with PBC [ Time Frame: 12 weeks ]
    To monitor adverse events


Estimated Enrollment: 45
Actual Study Start Date: April 5, 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Placebo
Two coated tablets daily for 12 weeks
Active Comparator: Elafibranor 80 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Elafibranor 80 mg
Two coated tablets daily for 12 weeks
Other Name: GFT505
Active Comparator: Elafibranor 120 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Elafibranor 120 mg
Two coated tablets daily for 12 weeks
Other Name: GFT505

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Must have provided written informed consent
  2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:

    • History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
    • Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
    • Liver biopsy consistent with PBC
  3. ALP ≥ 1.67x upper limit of normal (ULN)
  4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
  5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.

Exclusion Criteria:

  1. History or presence of other concomitant liver diseases
  2. Screening CPK > ULN
  3. Screening ALT or AST > 5 ULN
  4. Screening total bilirubin > 2 ULN
  5. Screening serum creatinine > 1.5 mg/dl
  6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m2).
  7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
  8. Platelet count <150 X 10 3/microliter
  9. Albumin <3.5 g/dL
  10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
  11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
  12. Known history of human immunodeficiency virus (HIV) infection
  13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
  Contacts and Locations
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): NCT03124108


Contacts
Contact: Sophie Megnien, MD +33 320 164 000 sophie.megnien@genfit.com
Contact: Charleen Pagel Jue, B.S., R.N. +33 320 164 000 charleen.pageljue@genfit.com

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact: Elizabeth J. Carey, MD    480-342-2000      
United States, Florida
Schiff Center for Liver Diseases Recruiting
Miami, Florida, United States, 33136
Contact: Cynthia Levy, MD    305-243-4615      
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Pratt, MD    617-724-3836      
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alan Bonder, MD    617-632-1086      
United States, New York
Northwell Health - Sandra Atlas Bass Center for Liver Disease Recruiting
Manhasset, New York, United States, 11030
Contact: Henry C. Bodenheimer, MD    516-562-4664      
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Marlyn Mayo, MD    214-648-2725      
Baylor College of Medicine - Advanced Liver Therapies Recruiting
Houston, Texas, United States, 77030
Contact: John M. Vierling, MD    832-355-8966      
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Stephen H. Caldwell, MD    434-924-2626      
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Velimir Luketic, MD    804-828-4060      
United States, Washington
Swedish Organ Transplant and Liver Center Recruiting
Seattle, Washington, United States, 98104
Contact: Kris Kowdley, MD    206-386-3880      
Germany
Clinic for Gastroenterology and Hepatology Recruiting
Köln, Germany, 50937
Contact: Münevver Demir, MD    +49 (0)2214 787334      
Johannes Gutenberg University Recruiting
Mainz, Germany, 55131
Contact: Jorn M Schattenberg, MD    +49 (0)6131 176831      
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Adolfo Gallego Moya, MD    +34 932 919-000      
Liver Unit, University of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Albert Pares, MD    +34 932 275-753      
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2GW
Contact: Gideon Hirschfield, MD    +44 (0)121 415-8700      
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: George Mells, MD    +44 (0)122 324-5151      
The Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Imran Patanwala, MD    +44 (0)151 706-2000      
Royal Free London NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW3 2QG
Contact: Douglas Thorburn, MD    +44 (0)207 794-0500      
Institute of Liver Studies, King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Michael Heneghan, MD    +44 (0)203 299-7615      
Royal Victoria Infirmary Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
Contact: David Jones, MD    +44 (0)191 222-8335      
Sponsors and Collaborators
Genfit
Investigators
Study Director: Sophie Megnien, MD Chief Medical Officer, Genfit
  More Information

Responsible Party: Genfit
ClinicalTrials.gov Identifier: NCT03124108     History of Changes
Other Study ID Numbers: GFT505B-216-1
2016-003817-80 ( EudraCT Number )
First Submitted: March 28, 2017
First Posted: April 21, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genfit:
Elafibranor
Primary Biliary Cholangitis
Alkaline phosphatase

Additional relevant MeSH terms:
Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents