Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
Status: Recruiting
Location: See all (46) locations...
Study Type: Observational
SUMMARY
This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Participant has provided written informed consent and agrees to comply with the study protocol.
• Participant with PBC diagnosis.
• Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.
• If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Locations
United States
California
Southern California Research Center
RECRUITING
Coronado
Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
University of California Davis Medical Center
NOT_YET_RECRUITING
Sacramento
Colorado
South Denver Gastroenterology,P.C.
RECRUITING
Englewood
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Florida
Schiff Center for Liver Diseases - University of Miami
RECRUITING
Miami
Massachusetts
Beth Israel Deaconess Medical Center, Liver Research Center
RECRUITING
Boston
New Jersey
Virtua Center for Liver Disease - Cherry Hill
RECRUITING
Cherry Hill
New York
Northwell Health Inc, Center for Liver Disease and Transplantation
RECRUITING
Manhasset
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Texas
Liver Center of Texas
RECRUITING
Dallas
Baylor College of Medicine - Advanced Liver Therapies
RECRUITING
Houston
Velocity Clinical Research
RECRUITING
Katy
Utah
Intermountain Medical Center
NOT_YET_RECRUITING
Murray
Virginia
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
RECRUITING
Richmond
Virginia Commonwealth University Medical Center - West Hospital
RECRUITING
Richmond
Washington
Gastro health & Nutrition
WITHDRAWN
Seattle
Other Locations
Austria
Medizinische Universitaetsklinik Graz
RECRUITING
Graz
Medical University Innsbruck
RECRUITING
Innsbruck
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
(G.I.R.I) GI Research Institute Foundation
RECRUITING
Vancouver
Germany
Charite Universitatsmedizin Berlin
RECRUITING
Berlin
DRK Kliniken Berlin Mitte
RECRUITING
Berlin
Klinikum der Johann Wolfgang Goethe-Universitaet
NOT_YET_RECRUITING
Frankfurt
Studiengesellschaft BSF
RECRUITING
Halle
Gastroenterologsiche Studiengesellschaft Herne
RECRUITING
Herne
Universitaet des Saarlandes
RECRUITING
Homburg
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Hospital of the Merciful Brothers Trier
RECRUITING
Trier
Greece
General Hospital of Athens Laiko
NOT_YET_RECRUITING
Athens
University Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Patras
RECRUITING
Pátrai
Ippokratio General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
United Arab Emirates
Clemenceau Medical Center Hospital
NOT_YET_RECRUITING
Dubai
Mediclinic Airport Road Hospital
NOT_YET_RECRUITING
Dubai
Sheikh Shakhbout Medical City
NOT_YET_RECRUITING
Dubai
United Kingdom
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
RECRUITING
Aberdeen
Belfast Health and Social Care Trust - Royal Victoria Hospital
RECRUITING
Belfast
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
RECRUITING
Bradford
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
King's College Hospital NHS Foundation Trust
RECRUITING
London
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
RECRUITING
Newcastle
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
NOT_YET_RECRUITING
Nottingham
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust