Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

Seladelpar 10 mg

Administered orally

DRUG

Placebo

Administered orally

Trial Locations (45)

10016

New York University (NYU) Langone Medical Center, New York

10065

Weill Cornell Medicine, New York

11030

Northwell Health Center for Liver Disease and Transplantation, Manhasset

11215

New-York-Presbyterian Brooklyn Methodist Hospital, Brooklyn

14642

University of Rochester Medical Center - Strong Memorial Hospital, Rochester

15213

UPMC Center for Liver Health, Pittsburgh

19104

Perelman Center for Advanced Medicine, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21202

Mercy Medical Center - Baltimore, Maryland, Baltimore

23226

Bon Secours Liver Institute of Hampton Roads, Richmond

30309

Digestive Healthcare of Georgia, Atlanta

33136

University of Miami - Schiff Center for Liver Diseases, Miami

33176

Gastro Health Research, Miami

33606

Covenant Metabolic Specialists, LLC, Tampa

33912

Covenant Metabolic Specialists, LLC, Sarasota

34211

Florida Research Institute, Lakewood Rch

37343

Galen Hepatology, Hixson

37604

Gastrointestinal Associates of Northeast Tennessee, P.C., Johnson City

38018

OGI - Gastro One, Cordova

45044

Gastro Health Research, Liberty Township

48377

Henry Ford Health System, Novi

55455

University of Minnesota, Minneapolis

60611

Northwestern Medicine Clinical Research Unit (CRU), Chicago

64131

Kansas City Research Institute, Kansas City

70112

Tulane University Medical Center, New Orleans

71105

Louisiana Research Center, LLC, Shreveport

75020

Soma Clinical Trials, LLC, Denison

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75234

Liver Center of Texas, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine - Baylor Clinic, Houston

Liver Associates of Texas, P.A., Houston

78757

American Research Corporation - San Antonio, TX, Austin

80045

University of Colorado Denver - School of Medicine - Anschutz Medical Campus, Aurora

80113

South Denver Gastroenterology, Englewood

85224

The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health, Chandler

91105

California Liver Research Institute, Pasadena

94115

California Pacific Medical Center, San Francisco

95817

University of California (UC) Davis Medical Center, Sacramento

98105

Velocity Clinical Research - Seattle, Seattle

98195

Stanford University, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

H2X3J4

Centre de Recherche du Centre Hospitallier de I'Universite de Montreal (CRCHUM), Montreal

V6Z 2K5

(G.I.R.I.) GI Research Institute Foundation, Vancouver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY