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

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 5, 2017

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Primary Biliary Cholangitis (PBC)
Interventions
DRUG

Elafibranor 80 mg

Two coated tablets daily for 12 weeks

DRUG

Elafibranor 120 mg

Two coated tablets daily for 12 weeks

DRUG

Placebo

Two coated tablets daily for 12 weeks

Trial Locations (24)

11030

Northwell Health Institution, Manhasset

22903

University of Virginia, Charlottesville

23298

Virginia Commonwealth University, Richmond

28801

Asheville Gastroenterology Associates, Asheville

30309

Piedmont Research Institute, Atlanta

33136

Schiff Center for Liver Diseases, Miami

33331

Cleveland Clinic Florida, Weston

50937

Clinic for Gastroenterology and Hepatology, Cologne

55131

Johannes Gutenberg University, Mainz

60590

University Hospital Frankfurt, Frankfurt

75012

Hopital Saint-Antoine, Paris

75390

UT Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

85054

Mayo Clinic in Arizona, Phoenix

98122

Swedish Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

08036

Liver Unit, University of Barcelona, Barcelona

08041

Hospital De La Sant Creu St. Pau, Barcelona

B15 2TT

University of Birmingham Centre for Liver Research, Birmingham

CB2 0QQ

Addenbrooke's Hospital, Cambridge

L7 8XP

The Royal Liverpool University Hospital, Liverpool

SE5 9RS

King's College Hospital, London

NE7 7DN

The Newcastle Upon Tyne Hosptials NHS Foundation Trust, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genfit

INDUSTRY

NCT03124108 - Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Biotech Hunter | Biotech Hunter