Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
NCT ID: NCT05525520
Last Updated: 2025-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2022-10-06
2024-09-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EP547 100 mg
EP547
Once daily
Placebo
Placebo
Once daily
Interventions
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EP547
Once daily
Placebo
Once daily
Eligibility Criteria
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Inclusion Criteria
* 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 additional relevant criteria
Exclusion Criteria
* 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 of biliary stent
* History of significant small bowel resection or short bowel syndrome
* Has exclusionary laboratory or biochemical results at Screening
18 Years
80 Years
ALL
No
Sponsors
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Escient Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
Dignity Health Center for Clinical Research at St. Joseph Hospital
Phoenix, Arizona, United States
Southern California Research Center
Coronado, California, United States
Science 37
Culver City, California, United States
California Liver Research Institute
Pasadena, California, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
NYU Grossman School of Medicine Gastroenterology and Hepatology
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Gastro Health Research
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Liver Associates of Texas, PA
Houston, Texas, United States
Gastro Health & Nutrition
Katy, Texas, United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
UZ Antwerpen
Antwerp, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
University of Alberta
Edmonton, Alberta, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Toronto Centre for Liver Disease Toronto General Hospital
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebeck, Canada
APHP Avicenne
Bobigny, , France
CHU Grenoble- Alpes- Site Nord
Grenoble, , France
CHU de Lille
Lille, , France
Saint Antoine Hospital
Paris, , France
Hospital Rangueil
Toulouse, , France
Paul Brousse Hospital
Villejuif, , France
Carmel Medical Center
Haifa, , Israel
Rambam Medical Center- Keriat Eliezer Family Health Center
Haifa, , Israel
Hadassah Medical Center (Ein-Karem)
Jerusalem, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Academic Medical Center- University of Amsterdam
Amsterdam, , Netherlands
Hospital General Universitario Alicante
Alicante, , Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital de Montecelo
Pontevedra, , Spain
Campus Hospital Universitario Virgen del Rocio
Seville, , Spain
La Fe University and Polytechnic Hospital
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Institute of Cellular Medicine, Newcastle University
Newcastle, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
Nottingham, , United Kingdom
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-002526-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP-547-201
Identifier Type: -
Identifier Source: org_study_id
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