RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Who is this study for? Patients with Primary Sclerosing Cholangitis
What treatments are being studied? Seladelpar
Status: Completed
Location: See all (133) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Must have given written informed consent (signed and dated) and any authorizations required by local law.

• Male or female with a definitive diagnosis of primary biliary cholangitis (PBC).

• Ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \>3 months prior to screening) or intolerant to UDCA (last dose of UDCA \>3 months prior to screening).

• Laboratory parameters measured by the Central Laboratory at screening:

‣ Alkaline phosphatase (ALP) ≥1.67× ULN (upper limit of normal)

⁃ Aspartate aminotransferase (AST) ≤3× ULN

⁃ Alanine aminotransferase (ALT) ≤3× ULN

⁃ Total bilirubin ≤2× ULN

⁃ Estimated glomerular filtration rate (eGFR) \>45 mL/min/1.73 m\^2 (calculated by the Modification of Diet in Renal Disease study equation).

⁃ International normalized ratio (INR) below 1.1× ULN (For individuals on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease).

⁃ Platelet count ≥100 ×10\^3/µL.

• Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.

Locations
United States
Arkansas
Arkansas Diagnostic Center
Little Rock
Arizona
The Institute for Liver Health DBA Arizona Liver Health
Chandler
California
Stanford University School of Medicine
Palo Alto
California Liver Research Institute
Pasadena
University of California, Davis Medical Center
Sacramento
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco
Florida
Covenant Metabolic Specialists, LLC
Fort Myers
Florida Research Institute
Lakewood Rch
Schiff Center for Liver Diseases/University of Miami
Miami
Covenant Research and Clinics, LLC
Sarasota
Georgia
Digestive Healthcare of Georgia
Atlanta
Illinois
Rush University Medical Center
Chicago
University of Chicago Hospitals
Chicago
Louisiana
Tulane University Health Sciences Center
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
Maryland
Mercy Medical Center
Baltimore
Michigan
Henry Ford Health System
Novi
Minnesota
MNGI Digestive Health, P.A.
Maplewood
Missouri
Saint Louis University
St Louis
Mississippi
Southern Therapy and Advanced Research, LLC (STAR)
Jackson
North Carolina
Care Access Research - Lumberton
Lumberton
New York
Icahn School of Medicine at Mount Sinai
New York
NYU Langone Health / NYU Grossman School of Medicine
New York
Weill Cornell Medical College
New York
University of Rochester Medical Center
Rochester
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey
UPMC Center for Liver Diseases
Pittsburgh
Tennessee
Galen Hepatology
Chattanooga
Gastro One
Germantown
Vanderbilt Digestive Disease Center
Nashville
Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas
University of Texas Southwestern Medical Center
Dallas
Texas Digestive Disease Consultants dba GI Alliance
Fort Hood
Baylor College of Medicine
Houston
American Research Corporation at the Texas Liver Institute
San Antonio
Pinnacle Clinical Research, PLLC
San Antonio
Virginia
Bon Secours Richmond Community Hospital LLC
Richmond
Washington
Liver Institute Northwest
Seattle
Other Locations
Argentina
CINME (Centro de Investigaciones Metabolicas)
Buenos Aires
Centro Medico Dra. De Salvo
Caba
Hospital Italiano de Buenos Aires
Caba
STAT Research S.A.
Ciudad Autonoma De Buenos Aire
Hospital Italiano de La Plata
La Plata
DIM CliniaPrivada
Ramos Mejía
Australia
Concord Repatriation General Hospital
Concord
Royal Brisbane & Women's Hospital
Herston
Alfred Hospital
Melbourne
The Royal Melbourne Hospital
Parkville
Austria
Klinikum Wels-Grieskirchen GmbH, Abteilung Fur Innere Medizin I - Gastroenterologie
Wels
Belgium
UZ Antwerpen
Edegem
AZ Maria Middelares
Ghent
Universitair Ziekenhuis Gent
Ghent
Universitaire Ziekenhuizen Leuven
Leuven
CHU de Liège
Liège
Canada
London Health Sciences Centre
London
University Health Network
Toronto
Toronto Digestive Disease Associates Inc
Vaughan
Chile
Centro Clinico Mediterraneo
La Serena
Clinical Research Chile SpA
Valdivia
Centro de Investigaciones Clínicas Vina del Mar
Valparaíso
Denmark
Aalborg Universitetshospital, Ambulatoriet for Medicinske Mave-Tarm Sygdomme
Aalborg
Hvidovre Hospital
Hvidovre
France
CHU de Grenoble
Grenoble
Hopital de la Croix-Rousse
Lyon
Hopital Saint-Antoine - Service d'Hepato-Gastro-Enterologie -184, rue du Faubourg Saint-Antoine
Paris
Germany
Universitätsklinikum Bonn
Bonn
Universitatsklinikum Erlangen, Medizinische Klinik I, Gastroenterologie
Erlangen
Universitatsklinikum Frankfurt. Medizinische Klinik I
Frankfurt Am Main
Ifi-Medizin GmbH
Hamburg
Gastroenterologische Gemeinschaftspraxis
Herne
Universitätsklinikum des Saarlandes
Homburg
Universitatsklinikum Leipzig
Leipzig
Greece
Ippokrateio General Hospital of Athens
Athens
General University Hospital of Larissa Department of Medicine and Research Laboratory of internal rv1edicine, National Expertise Center of Greece in Autoimmune liver Diseases
Larissa
Hungary
Semmelweis Egyetem
Budapest
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Israel
Liver Unit
Jerusalem
Liver Disease Center, Sheba Medical Center
Ramat Gan
Institute for Digestive Tract & Liver Disease
Tel Aviv
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona
Nuovo Ospedale Civile S. Agostino-Estense di Baggiovara
Bologna
Azienda Ospedaliero Universitaria Careggi
Florence
ASST di Monza
Monza
Azienda Ospedaliera Universita Padova
Padua
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo
Mexico
Consultorio de la Doctora Maria Sarai Gonzalez Huezo
Metepec
Campeche No. 280, Int. 601 y 602, Col. Hipodromo, Cuauhtemoc
Mexico City
Consultorio Medico - Distrito Federal
Mexico City
Hospital Universitario Dr. Jose Eleuterio González
Monterrey
New Zealand
Gastroenterology, Christchurch Hospital
Christchurch
Gastroenterology Research Unit Dunedin Hospital
Dunedin
Poland
Uniwersyteckie Centrum Kliniczne Im.
Katowice
ID Clinic Akradiusz Pisula
Mysłowice
Republic of Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Inje University Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Kyungpook National University Hospital
Daegu
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System - PPDS
Soeul
Romania
Fundeni Clinical Institute
Bucharest
Russian Federation
Federal State Autonomous Educational Institution of Higher Education Peoples' Friendship University of Russia, Centre of Liver Studies
Moscow
State budget institution of healthcare of Moscow city Moscow Clinical Scientific and Practical Centre n. a. A.S. Loginov of Moscow City Healthcare, Department, Central Research Institute of Gastroenterology
Moscow
Clinic of High Medical Technologies n.a. N.I. Pirogov
Saint Petersburg
LLC Medical Company Hepatolog
Samara
Stavropol state medical university
Stavropol
Ulyanovsk Regional Clinical Hospital
Ulyanovsk
Spain
Hospital Universitario German Trias i Pujol
Badalona
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Vall D'Hebron
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Margues de Valdecilla
Santander
Switzerland
University of Zurich, Gastroenterology and Hepatology
Zurich
Turkey
Ankara Gazi University Faculty of Medicine Hospital
Ankara
Ankara Sehir Hastanesi
Ankara
Bezmi Alem University
Istanbul
Marmara University Pendik Training and Research Hospital
Istanbul
Ege University Medical Faculty
Izmir
Ukraine
Municipal Non-profit Enterprise City Clinical Hospital #13 of Kharkiv City Council
Kharkiv
Medical Center OK!Clinic+LLC International Institute of Clinical Research
Kyiv
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Heritage Building (Queen Elizabeth Hospital)
Birmingham
Hull Royal Infirmary
Hull
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
London
Kings College Hospital
London
Queen's Medical Centre
Nottingham
Gemini Clinical Trial Unit
Oxford
University Hospitals Plymouth NHS Trust
Plymouth
Portsmouth Hospitals NHS Trust
Portsmouth
Time Frame
Start Date: 2021-04-21
Completion Date: 2023-08-11
Participants
Target number of participants: 193
Treatments
Placebo_comparator: Placebo
Participants will receive placebo to match seladelpar, orally, once daily, for a duration of up to 12 months.
Experimental: Seladelpar
Participants will receive seladelpar 10 mg (or 5 mg down-titrated, for those participants who met specific safety monitoring criteria or had tolerability issues), orally, once daily, for a duration of up to 12 months.
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov

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