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

Primary Purpose

Primary Biliary Cirrhosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Elafibranor 80mg
Placebo
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring Primary Biliary Cholangitis, PBC, Elafibranor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Institute for Liver Health
  • Keck Medical Center of USC
  • Ruane Clinical Research Group Inc.
  • Cedars-Sinai Medical Center
  • University of California, Davis Medical Center
  • California Pacific Medical Center - Sutter Pacific Medical Foundation
  • University of Colorado Denver and Hospital
  • South Denver Gastroenterology, P.C.
  • Yale School of Medicine, Digestive Diseases
  • Encore Borland-Groover Clinical Research
  • Schiff Center for Liver Diseases/University of Miami
  • Digestive Healthcare of Georgia
  • University of Kansas Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center (BIDMC)
  • Henry Ford Health System
  • Saint Louis University
  • UPMC Center for Liver Diseases
  • NYU Langone Health / NYU Grossman School of Medicine
  • Columbia University Medical Center - Center for Liver Disease and Transplantation
  • The New York-Presbyterian Hospital, David H. Koch Center
  • Duke University Medical Center
  • Carolinas Centre for Liver disease/ Atrium Health
  • Consultants for Clinical Research
  • University Hospitals Cleveland Medical Center
  • The Ohio State University Wexner Medical Center
  • Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center
  • Thomas Jefferson University
  • Medical University of South Carolina- College of Medicine
  • Vanderbilt Digestive Disease Center
  • Texas Clinical Research Institute, LLC
  • The Liver Institute at Methodist Dallas Medical Center
  • Liver Center of Texas, PLLC
  • The University of Texas Southwestern Medical Center-IDS Aston Pharmacy
  • Texas Digestive Disease Consultants dba GI Alliance
  • Liver Associates of Texas, P.A.
  • St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research
  • American Research Corporation
  • Gastro health & Nutrition-Victoria
  • Intermountain Medical Center - Transplant Services
  • University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition
  • University of Virginia Medical Center
  • Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads
  • Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond
  • Virginia Commonwealth University Clinical Research Services Unit (CRSU)
  • Liver Institute Northwest
  • Hospital Italiano de Buenos Aires
  • Hospital Alemán
  • Hospital Británico de Buenos Aires
  • Hospital Espanol De Mendoza
  • Hospital Italiano de La Plata
  • Hospital Provincial del Centenario
  • Hôpital Erasme
  • Antwerp University Hospital
  • Universitair Ziekenhuis Gent
  • University Hospital Leuven
  • Hospital de Clínicas de Porto Alegre
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
  • University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
  • Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
  • Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre
  • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
  • Hospital de La Serena
  • Centro de Investigaciones Clinicas (CIC)
  • Clínica Universidad de los Andes
  • Hospital Clínico Universidad de Chile
  • Centro de Investigacion Clinica Universidad Catolica CICUC
  • CHU Amiens Picardie
  • Hôpital Henri Mondor
  • CHU Grenoble Alpes - Hôpital Albert Michallon
  • Centre Hospitalier Régional d'Orléans
  • Hôpital Saint-Antoine
  • Hôpital Cochin
  • Hôpital Pitié-Salpétrière
  • Hôpital Haut Lévêque
  • Hôpital Robert Debré - CHU de Reims
  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
  • Gastro - Sudien
  • Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik
  • Universitätsklinikum Frankfurt
  • Medizinische Hochschule Hannover
  • Center for Gastroenterology and Hepatology (GHZ) Kiel
  • EUGASTRO GmbH
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia
  • ASST Monza - Ospedale San Gerardo, Gastroenterologia
  • Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia
  • Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica
  • Tiervlei Trial Centre
  • Groote Schuur Hospital, University of Cape Town - Clinical Research Centre
  • Mediclinic Constantiaberg, North Suites
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro -Madrid
  • Complexo Hospitalario Universitario de Pontevedra
  • Hospital Universitario Donostia
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen del Rocio
  • Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie
  • Fondazione Epatocentro Ticino
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali
  • Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital
  • Belfast Health and Social Care Trust-Royal Victoria Hospital
  • Frimley Health NHS Foundation Trust - Frimley Park Hospital
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
  • Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary
  • King's College Hospital. King's College NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
  • Plymouth Hospitals NHS Trust, Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elafibranor 80mg

Placebo

Arm Description

Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning

Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning

Outcomes

Primary Outcome Measures

Effect of elafibranor (80 mg/day) on cholestasis
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

Response to treatment based on ALP normalization
Change in pruritus from baseline in patients with baseline PBC Worst Itch NRS Score ≥ 4
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)
Change in pruritus from baseline in patients with baseline PBC Worst Itch NRS Score ≥ 4
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)

Full Information

First Posted
August 21, 2020
Last Updated
October 6, 2023
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT04526665
Brief Title
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Acronym
ELATIVE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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). In the DB period, patients will be randomized in a 2:1 ratio to receive Elafibranor 80 mg or placebo, once daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
Primary Biliary Cholangitis, PBC, Elafibranor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind (DB), randomized, placebo-controlled study followed by an open-label long term extension (LTE)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elafibranor 80mg
Arm Type
Experimental
Arm Description
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study subjects will take 1 tablet per day orally before breakfast with a glass of water each morning
Intervention Type
Drug
Intervention Name(s)
Elafibranor 80mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Effect of elafibranor (80 mg/day) on cholestasis
Description
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
Time Frame
From baseline to 52 weeks of treatment
Secondary Outcome Measure Information:
Title
Response to treatment based on ALP normalization
Time Frame
At Week 52
Title
Change in pruritus from baseline in patients with baseline PBC Worst Itch NRS Score ≥ 4
Description
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)
Time Frame
Through 52 weeks of treatment
Title
Change in pruritus from baseline in patients with baseline PBC Worst Itch NRS Score ≥ 4
Description
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)
Time Frame
Through 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center - Sutter Pacific Medical Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
University of Colorado Denver and Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
840045
Country
United States
Facility Name
South Denver Gastroenterology, P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Yale School of Medicine, Digestive Diseases
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Encore Borland-Groover Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
UPMC Center for Liver Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042-11114
Country
United States
Facility Name
NYU Langone Health / NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center - Center for Liver Disease and Transplantation
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The New York-Presbyterian Hospital, David H. Koch Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolinas Centre for Liver disease/ Atrium Health
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina- College of Medicine
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt Digestive Disease Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Liver Center of Texas, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
The University of Texas Southwestern Medical Center-IDS Aston Pharmacy
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8575
Country
United States
Facility Name
Texas Digestive Disease Consultants dba GI Alliance
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Liver Associates of Texas, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Gastro health & Nutrition-Victoria
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Intermountain Medical Center - Transplant Services
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Commonwealth University Clinical Research Services Unit (CRSU)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Hospital Alemán
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Británico de Buenos Aires
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Hospital Espanol De Mendoza
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
5547
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Provincia De Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Hospital Provincial del Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z IM9
Country
Canada
Facility Name
Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
City
Montréal
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Hospital de La Serena
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1700000
Country
Chile
Facility Name
Centro de Investigaciones Clinicas (CIC)
City
Viña Del Mar
State/Province
Region De Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Clínica Universidad de los Andes
City
Santiago
ZIP/Postal Code
7550000
Country
Chile
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
ZIP/Postal Code
8320000
Country
Chile
Facility Name
Centro de Investigacion Clinica Universidad Catolica CICUC
City
Santiago
ZIP/Postal Code
8330034
Country
Chile
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU Grenoble Alpes - Hôpital Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Haut Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Robert Debré - CHU de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Gastro - Sudien
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Center for Gastroenterology and Hepatology (GHZ) Kiel
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale
City
Modena
State/Province
Località Baggiovara
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
ASST Monza - Ospedale San Gerardo, Gastroenterologia
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Tiervlei Trial Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Groote Schuur Hospital, University of Cape Town - Clinical Research Centre
City
Cape Town
State/Province
Western Cap
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Mediclinic Constantiaberg, North Suites
City
Cape Town
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro -Madrid
City
Madrid
ZIP/Postal Code
C.P 28222
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Fondazione Epatocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital
City
Newcastle-upon-Tyne
State/Province
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust-Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Frimley Health NHS Foundation Trust - Frimley Park Hospital
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary
City
Hull
ZIP/Postal Code
HU32J
Country
United Kingdom
Facility Name
King's College Hospital. King's College NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
City
Nottingham
ZIP/Postal Code
NG72UH
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust, Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD Sharing Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD Sharing Access Criteria
Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
IPD Sharing URL
https://vivli.org/members/ourmembers/

Learn more about this trial

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

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