A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant. The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death). This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.

• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Locations
United States
Arkansas
Arkansas Diagnostic Center, PA
TERMINATED
Little Rock
Arizona
Arizona Liver Health
RECRUITING
Tucson
California
Southern California Research Center
RECRUITING
Coronado
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
GastroIntestinal BioSciences
RECRUITING
Los Angeles
University of California Los Angeles
WITHDRAWN
Los Angeles
University of California Davis Medical Center
NOT_YET_RECRUITING
Sacramento
Colorado
University of Colorado
RECRUITING
Aurora
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
South Denver Gastroenterology, P.C.
RECRUITING
Englewood
Rocky Mountain Gastroenterology
RECRUITING
Littleton
Florida
University Of Miami School Of Medicine, Center For Liver Diseases
RECRUITING
Miami
International Center for Research
RECRUITING
Tampa
Kansas
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
NOT_YET_RECRUITING
Kansas City
Louisiana
Louisiana Research Center, LLC
RECRUITING
Shreveport
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Huron Gastroenterology Associates - Center for Digestive Care
RECRUITING
Ypsilanti
New Mexico
Southwest Gastroenterology Associates, PC (SWGA)
RECRUITING
Albuquerque
New York
NYU Langone Gastroenterology and Hepatology Associates
RECRUITING
New York
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Gastroenterology Center of the Midsouth
RECRUITING
Cordova
Texas
Texas Clinical Research Institute
RECRUITING
Arlington
American Research Corporation
RECRUITING
Austin
Liver Center of Texas
RECRUITING
Dallas
Methodist Transplant Physicians
RECRUITING
Dallas
Rush University Medical Center - University Cardiovascular Surgeons
WITHDRAWN
Dallas
University of Texas Southwestern Medical Center at Dallas
RECRUITING
Dallas
Baylor Scott & White All Saints Medical Center - Forth Worth
WITHDRAWN
Fort Worth
Houston Methodist Cancer Center
RECRUITING
Houston
Liver Associates of Texas
RECRUITING
Houston
Gastro health & Nutrition
WITHDRAWN
Katy
American Research Corporation at The Texas Liver Institute
RECRUITING
San Antonio
Impact Research Tx
RECRUITING
Waco
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Bon Secours St. Mary's Hospital of Richmond, Inc
RECRUITING
Richmond
Virginia Commonwealth University Medical Center - West Hospital
NOT_YET_RECRUITING
Richmond
Washington
Medstar Georgetown Transplant Institute University Hospital (MGUH)
WITHDRAWN
Columbia
Velocity Clinical Research at Liver Institute Northwest
RECRUITING
Seattle
Other Locations
Argentina
DIM Centro Medico
NOT_YET_RECRUITING
Buenos Aires
Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
RECRUITING
Buenos Aires
Hospital Britanico de Buenos Aires
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Centro Medico Colon
RECRUITING
Córdoba
Hospital Espanol de Mendoza
RECRUITING
Mendoza
Hospital Universitario Austral
RECRUITING
Pilar
Hospital El Cruce
NOT_YET_RECRUITING
San Juan Bautista
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Footscray Hospital, Western Health
RECRUITING
Footscray
Nepean Clinical School
RECRUITING
Kingswood
Monash University - Monash Health -Monash Medical Centre
RECRUITING
Melbourne
St George Hospital
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Westmead
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Gent University Hospital
RECRUITING
Ghent
Algemeen Ziekenhuis Delta
RECRUITING
Roeselare
Brazil
NUPEC Cardio
RECRUITING
Belo Horizonte
Universidade Federal de Goias
RECRUITING
Goiânia
Hospital de Clinicas de Porto Alegre (HCPA)
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING
São Paulo
Hospital de Base - Centro Integrado de Pesquisa ( CIP )
RECRUITING
São Paulo
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
RECRUITING
São Paulo
Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
RECRUITING
Sofia
Tokuda Hospital, Dept. of Internal Medicine
RECRUITING
Sofia
University Hospital City Clinic Cancer Center
RECRUITING
Sofia
Canada
University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)
RECRUITING
Edmonton
University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)
RECRUITING
Toronto
Chile
Universidad De Los Andes
RECRUITING
Las Condes
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
RECRUITING
Santiago
Enroll SpA
RECRUITING
Santiago
Hospital Clinico de la Pontificia Universidad Catolica de Chile
RECRUITING
Santiago
University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)
NOT_YET_RECRUITING
Santiago
Centro Medico Cedid - Centro de Diagnostico Digestivo
RECRUITING
Viña Del Mar
Denmark
Bispebjerg Hospital
RECRUITING
Copenhagen
France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
RECRUITING
Lille
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
RECRUITING
Lyon
Hopital Saint Joseph - Marseille
WITHDRAWN
Marseille
CHU de Nice, Hopital de l'Archet
RECRUITING
Nice
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
WITHDRAWN
Paris
CHU Poitiers
RECRUITING
Poitiers
Clinique Pasteur
RECRUITING
Toulouse
Hopital Paul-Brousse - APHP
RECRUITING
Villejuif
Greece
Agios Savvas Regional Cancer Hospital
RECRUITING
Athens
General Hospital of Athens Laiko
RECRUITING
Athens
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
RECRUITING
Athens
GeneIppokratio General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Central Hospital of Northern Pest - Military Hospital
RECRUITING
Budapest
Kenezy County Hospital
RECRUITING
Debrecen
Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika
RECRUITING
Szeged
Israel
Hadassah University Hospital (HUH) - Ein-Kerem
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Italy
Azienda Ospedaliero Universitaria Modena
RECRUITING
Modena
Ospedale San Gerardo
RECRUITING
Monza
Azienda Ospedaliero Universitaria Federico II di Napoli
RECRUITING
Naples
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
RECRUITING
Padua
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
RECRUITING
Palermo
Fondazione I.R.C.C.S. Policlinico San Matteo
WITHDRAWN
Pavia
Azienda Ospedaliero Universitaria Pisana
NOT_YET_RECRUITING
Pisa
Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Mexico
Centro de Investigacion Medico Biologica y Terapia Avanzada
NOT_YET_RECRUITING
Jalisco
Centro de Investigacion y Gastroenterologia SC
NOT_YET_RECRUITING
Mexico City
Medical Care & Research
NOT_YET_RECRUITING
Yucatán
New Zealand
Canterbury District Health Board
RECRUITING
Christchurch
Waikato Hospital
RECRUITING
Hamilton
Poland
NZOZ Twoje Zdrowie EL Sp. z o.o.
RECRUITING
Elblag
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
RECRUITING
Katowice
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
RECRUITING
Krakow
Szpital Uniwersytecki w Krakowie
WITHDRAWN
Krakow
Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
NOT_YET_RECRUITING
Małogoskie
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
RECRUITING
Rzeszów
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
WITHDRAWN
Sosnowiec
FutureMeds Warszawa Centrum
RECRUITING
Warsaw
FutureMeds sp. z o. o
RECRUITING
Wroclaw
Nzoz Centrum BadanKlinicznych
RECRUITING
Wroclaw
PlanetMed Sp. z o.o.
RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital (PNUH)
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
The Catholic University of Korea Daejeon St.Mary's Hospital
RECRUITING
Daejeon
Inje University Ilsan Paik Hospital
RECRUITING
Goyang-si
Korea University Ansan Hospital
RECRUITING
Gyeonggi-do
Inha University Hospital
RECRUITING
Incheon
Kyungpook National University Hospital (KNUH)
RECRUITING
Junggu
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Chung-Ang University Hospital
RECRUITING
Seoul
Hallym University Kangnam Sacred Heart Hospital
WITHDRAWN
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Bundang Hospital (SNUBH)
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
RECRUITING
Uijeongbu-si
Romania
Centrul Pentru Studiul Metabolismului
RECRUITING
Bucharest
Sana S.R.L
RECRUITING
Bucharest
Spital Clinic Dr I Cantacuzino
RECRUITING
Bucharest
Cluj County Clinical Emergency Hospital
RECRUITING
Cluj-napoca
Gastromedica Srl
RECRUITING
Iași
Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Clinica Universidad Navarra-Sede Madrid
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon (HGUGM)
RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
RECRUITING
Majadahonda
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital De Montecelo
WITHDRAWN
Pontevedra
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitario y Politecnico La Fe
RECRUITING
Valencia
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Ipsen Clinical Study Enquiries
clinical.trials@ipsen.com
See e mail
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 276
Treatments
Experimental: Elafibranor 80 mg
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.
Placebo_comparator: Placebo
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.
Sponsors
Leads: Ipsen

This content was sourced from clinicaltrials.gov