Phase
Condition
Hives (Urticaria)
Liver Disorders
Liver Disease
Treatment
EP547
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 80 years
Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
Presence of consistent moderate to severe pruritus
Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid)medication allowed if meeting additional criteria
Individuals with concomitant inflammatory bowel disease must meet additionalrelevant criteria
Exclusion
Exclusion Criteria:
Pruritus associated with an etiology other than PBC or PSC
Prior or planned liver transplantation
Evidence of compensated or decompensated cirrhosis
Alternative causes of liver disease
Presence of documented secondary sclerosing cholangitis
Current evidence of clinically significant high-grade strictures or presence ofbiliary stent
History of significant small bowel resection or short bowel syndrome
Has exclusionary laboratory or biochemical results at Screening
Study Design
Connect with a study center
UZ Antwerpen
Antwerpen,
BelgiumSite Not Available
UZ Gent
Gent,
BelgiumSite Not Available
UZ Leuven
Leuven,
BelgiumSite Not Available
University of Alberta
Edmonton, Alberta T6G 2X8
CanadaSite Not Available
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia
CanadaSite Not Available
Toronto Centre for Liver Disease Toronto General Hospital
Toronto, Ontario
CanadaSite Not Available
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebeck H2X 0A9
CanadaSite Not Available
APHP Avicenne
Bobigny,
FranceSite Not Available
CHU Grenoble- Alpes- Site Nord
Grenoble,
FranceSite Not Available
CHU de Lille
Lille,
FranceSite Not Available
Saint Antoine Hospital
Paris,
FranceSite Not Available
Hospital Rangueil
Toulouse,
FranceSite Not Available
Paul Brousse Hospital
Villejuif,
FranceSite Not Available
Carmel Medical Center
Haifa,
IsraelSite Not Available
Rambam Medical Center- Keriat Eliezer Family Health Center
Haifa,
IsraelSite Not Available
Hadassah Medical Center (Ein-Karem)
Jerusalem,
IsraelSite Not Available
Chaim Sheba Medical Center
Ramat Gan,
IsraelSite Not Available
Academic Medical Center- University of Amsterdam
Amsterdam,
NetherlandsSite Not Available
Hospital General Universitario Alicante
Alicante,
SpainSite Not Available
Hospital Clinic Barcelona
Barcelona,
SpainSite Not Available
Hospital de Montecelo
Pontevedra,
SpainSite Not Available
Campus Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
La Fe University and Polytechnic Hospital
Valencia,
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza,
SpainSite Not Available
University Hospitals Birmingham NHS Foundation Trust
Birmingham,
United KingdomSite Not Available
Glasgow Royal Infirmary
Glasgow,
United KingdomSite Not Available
King's College Hospital NHS Foundation Trust
London,
United KingdomSite Not Available
Institute of Cellular Medicine, Newcastle University
Newcastle,
United KingdomSite Not Available
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich,
United KingdomSite Not Available
University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
Nottingham,
United KingdomSite Not Available
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth,
United KingdomSite Not Available
University of Alabama Birmingham Hospital
Birmingham, Alabama 35294
United StatesSite Not Available
Dignity Health Center for Clinical Research at St. Joseph Hospital
Phoenix, Arizona 85013
United StatesSite Not Available
Southern California Research Center
Coronado, California 92118
United StatesSite Not Available
Science 37
Culver City, California 90230
United StatesSite Not Available
California Liver Research Institute
Pasadena, California 91105
United StatesSite Not Available
University of Miami - Schiff Center for Liver Diseases
Miami, Florida 33136
United StatesSite Not Available
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Tulane University Health Sciences Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Southern Therapy and Advanced Research
Jackson, Mississippi 39216
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
NYU Grossman School of Medicine Gastroenterology and Hepatology
New York, New York 10016
United StatesSite Not Available
Gastro Health Research
Cincinnati, Ohio 45249
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas 75203
United StatesSite Not Available
Liver Associates of Texas, PA
Houston, Texas 77030
United StatesSite Not Available
Gastro Health & Nutrition
Katy, Texas 77494
United StatesSite Not Available
Digestive & Liver Disease Specialists
Norfolk, Virginia 23502
United StatesSite Not Available
Bon Secours Liver Institute of Virginia
Richmond, Virginia 23226
United StatesSite Not Available
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