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Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)

Primary Purpose

Primary Sclerosing Cholangitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cilofexor
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of large duct PSC
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:

    • Platelet count ≥ 150,000/mm^3
    • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
    • ALT ≤ 8 x upper limit of the normal range (ULN)
    • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
    • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
    • Negative anti-mitochondrial antibody

Key Exclusion Criteria:

  • Current or prior history of any of the following:

    • Cirrhosis
    • Liver transplantation
    • Cholangiocarcinoma or hepatocellular carcinoma (HCC)
    • Ascending cholangitis within 30 days of screening
  • Presence of a percutaneous drain or biliary stent
  • Other causes of liver disease
  • Current or prior history of unstable cardiovascular disease
  • Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • Institute For Liver Health
  • The Institute for Liver Heath
  • Southern California Research Center
  • Altman Clinical and Translational Research Institute (Clinic)
  • Scripps Clinic/Green Hospital
  • Ruane Clinical Research Group Inc.
  • Stanford Hospital
  • California Liver Research Institute
  • University of California, Davis Medical Center (study visits)
  • Sutter Pacific Medical Foundation - California Pacific Medical Center
  • University of California, San Francisco Liver Clinic
  • Cedars Sinai Medical Center
  • University of Colorado Denver and Hospital
  • Peak Gastroenterology Associates
  • South Denver Gastroenterology, PC
  • Yale School of Medicine
  • MedStar Georgetown University Hospital
  • Schiff Center for Liver Diseases/University of Miami
  • Advanced Research Institute, Inc
  • Advanced Medical Research Center
  • Cleveland Clinic Florida
  • Piedmont Atlanta Hospital
  • Northwestern Memorial Hospital; Clinical Research Unit
  • Rush University Medical Center
  • University of Chicago Medical Center (outpatient clinic)
  • NorthShore University Healthsystem
  • IU Health University Hospital
  • University of Kansas Hospital
  • Ochsner Clinic Foundation
  • Louisiana Research Center, LLC
  • Mercy Medical Center
  • Walter Reed National Military Medical Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • NECCR PrimaCare Research, LLC
  • Michigan Medicine - University of Michigan
  • Henry Ford Hospital
  • Minnesota Gastroenterology, PA
  • Mayo Clinic
  • Southern Therapy and Advanced Research LLC
  • Saint Louis University, Gastroenterology & Hepatology
  • University of Nebraska Medical Center
  • Rutgers New Jersey Medical School - Doctors Office Center
  • Montefiore Medical Center
  • Northwell Health Center for Liver Diseases and Transplantation
  • NYU Langone Health
  • Weill Cornell Medical College
  • Icahn School of Medicine at Mount Sinai Beth Israel
  • Mount Sinai Medical Center
  • Center for Liver Disease and Transplantation, Columbia University Medical Center
  • University of Rochester Medical Center
  • The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
  • Carolinas Medical Center - Center for Liver Disease
  • Duke University Medical Center
  • Wake Forest Baptist Health
  • Holmes Hospital
  • Penn State Health Milton S. Hershey Medical Center
  • Thomas Jefferson University
  • Einstein Medical Center
  • Reading Hospital
  • University Gastroenterology
  • Medical University of South Carolina
  • Rapid City Medical Center, LLP
  • Methodist University Hospital
  • Vanderbilt University Medical Center - Digestive Disease Center
  • Texas Clinical Research Institute
  • The Liver Institute at Methodist Dallas Medical Center
  • Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas
  • Baylor Scott & White Medical Center at Fort Worth
  • Baylor College of Medicine - Advanced Liver Therapies
  • Spring Gastroenterology Associates
  • San Antonio Military Medical Center, Gastro/Hepatology
  • Intermountain Medical Center - Transplant Services
  • University of Utah Hospital
  • The University of Vermont Medical Center
  • University of Virginia Medical Center
  • Verity Research Inc.
  • Bon Secours Richmond Community Hospital
  • Virginia Commonwealth University Clinical Research Services Unit
  • Virginia Mason Medical Center
  • Harborview Medical Center
  • Liver Institute Northwest
  • Royal Prince Alfred Hospital
  • St. Vincent's Hospital Sydney
  • Nepean Hospital
  • Westmead Hospital
  • Coral Sea Clinical Research Institute - Mackay
  • Royal Brisbane and Women's Hospital
  • Mater Misericordiae Ltd
  • Monash Health
  • Austin Health
  • The Alfred Hospital
  • The Royal Melbourne Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee
  • Allgemeines Krankenhaus Wien
  • Hôpital Erasme - ULB
  • Universitair Ziekenhuis Antwerpen
  • Universitair Ziekenhuis Gent
  • Algemeen Ziekenhuis Maria Middelares
  • Universitair Ziekenhuis Leuven
  • Centre Hospitalier Universitaire de Liège Site Sart Tilman
  • William Osler Health System - Brampton Civic Hospital
  • University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
  • Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
  • St. Joseph's Healthcare Hamilton
  • McMaster University Medical Center
  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
  • Chronic Viral Illness Service/McGill University Health Centre (MUHC)
  • Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
  • Toronto Liver Centre
  • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
  • (G.I.R.I.) GI Research Institute
  • University of Manitoba/Health Sciences Centre
  • Aalborg University Hospital
  • Copenhagen University Hospital - Hvidovre
  • Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala
  • Turku University Hospital, Gastroenterology Outpatient Clinic
  • Hôpital Saint-Eloi
  • CHU Amiens-Picardie Hôpital Sud
  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Hôpital Henri Mondor
  • CHU Grenoble Alpes
  • Hôpital Saint-Joseph
  • Hopital Saint Antoine
  • CHU Bordeaux-Hopital Haut-Leveque
  • Hopital Robert Debré - Centre Hospitalier Universitaire de Reims
  • CHU de Strasbourg - Nouvel Hôpital Civil
  • CHU de Toulouse Hopital Ranguiel
  • CHU de Toulouse - Hopital Rangueil
  • Hopital Paul Brousse
  • GASTRO-Studien GbR
  • Universitätsklinikum Essen
  • Universitätsklinikum Frankfurt
  • Medizinische Hochscule Hannover
  • Universitätsklinik Heidelberg
  • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie
  • Gastroenterologisch-Hepatologisches Zentrum Kiel
  • Universitätsklinikum Leipzig AöR
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • Universitätsmedizin Mannheim, II. Medizinische Klinik
  • Emek Medical Center
  • Rambam Health Care Campus
  • Carmel Medical Center
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Ein Kerem
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • IRCCS Ospedale Sollievo della Sofferenza
  • Dipartimento Gastroenterologico e dei Trapianti
  • Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara
  • Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia
  • Medicina Interna 1
  • Azienda Ospedale Universita Padova
  • Azienda Ospedaliera Universitaria Policlinico P. Giaccone
  • Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Istituto Clinico Humanitas - Unita Operativa di Epatologia
  • U.O.C. Gatroenterologia
  • Chiba University Hospital
  • Hiroshima University Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Okayama University Hospital
  • National University Corporation Tohoku University Tohoku University Hospital
  • Osaka University Hospital
  • Juntendo University Hospital
  • Teikyo University Hospital
  • Ehime University Hospital
  • Yamagata University Hospital
  • Auckland City Hospital
  • Christchurch Hospital
  • Waikato Hospital
  • Hospital General Universitario de Alicante
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario de la Princesa
  • Hospital Universitario Ramon y cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Complejo Hospitalario de Pontevedra
  • Hospital Clinico Universitario Santiago de Compostela
  • Hospital General Universitario de Valencia
  • Hospital Universitari Politecnic La Fe de Valencia
  • Hospital Universitario Miguel Servet
  • Universitatsspital Bern
  • Epatocentro Ticino SA
  • Universitatsspital Zurich
  • University Hospital Birmingham NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • NHS Greater Glasgow and Clyde
  • The Leeds Teaching Hospitals NHS Trust
  • Aintree University Hospitals NHS Foundation Trust
  • Barts Health NHS Trust
  • Royal Free London NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Oxford University Hospitals NHS Foundation Trust
  • Portsmouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Blinded Phase: Cilofexor

Blinded Phase: Placebo

Open-Label Phase: Cilofexor

Arm Description

Cilofexor for 96 weeks

Placebo for 96 weeks

Cilofexor for 96 weeks

Outcomes

Primary Outcome Measures

Proportion of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
Progression of liver fibrosis was defined as having a ≥ 1-stage increase in fibrosis according to the Ludwig classification. The proportion of participants with progression of liver fibrosis at blinded phase Week 96 will be presented.

Secondary Outcome Measures

Percentage of Participants Experiencing Adverse Events (AEs)
Percentage of Participants Experiencing Serious Adverse Events (SAE
Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96
Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96
Change From Baseline in Serum Concentrations of Bile Acids at Blinded Phase Week 96
Composite Endpoint Measuring the Proportion of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96
Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96
Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 based on disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96
Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96

Full Information

First Posted
March 25, 2019
Last Updated
July 25, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03890120
Brief Title
Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis
Acronym
PRIMIS
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Following recommendation of the external Data Monitoring Committee, after it reviewed the results of a planned interim futility analysis.
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinded Phase: Cilofexor
Arm Type
Experimental
Arm Description
Cilofexor for 96 weeks
Arm Title
Blinded Phase: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 96 weeks
Arm Title
Open-Label Phase: Cilofexor
Arm Type
Experimental
Arm Description
Cilofexor for 96 weeks
Intervention Type
Drug
Intervention Name(s)
Cilofexor
Other Intervention Name(s)
GS-9674
Intervention Description
100 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
Proportion of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
Description
Progression of liver fibrosis was defined as having a ≥ 1-stage increase in fibrosis according to the Ludwig classification. The proportion of participants with progression of liver fibrosis at blinded phase Week 96 will be presented.
Time Frame
Blinded Phase Week 96
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame
Up to 4 years
Title
Percentage of Participants Experiencing Serious Adverse Events (SAE
Time Frame
Up to 4 years
Title
Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Change From Baseline in Serum Concentrations of Bile Acids at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Composite Endpoint Measuring the Proportion of Participants With ≥ 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Proportion of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96
Time Frame
Blinded Phase Week 96
Title
Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 based on disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96
Title
Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96
Time Frame
Baseline; Blinded Phase Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of large duct PSC Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory: Platelet count ≥ 150,000/mm^3 Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation ALT ≤ 8 x upper limit of the normal range (ULN) Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation Negative anti-mitochondrial antibody Key Exclusion Criteria: Current or prior history of any of the following: Cirrhosis Liver transplantation Cholangiocarcinoma or hepatocellular carcinoma (HCC) Ascending cholangitis within 30 days of screening Presence of a percutaneous drain or biliary stent Other causes of liver disease Current or prior history of unstable cardiovascular disease Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis) Note: Other protocol defined Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute For Liver Health
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
The Institute for Liver Heath
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Altman Clinical and Translational Research Institute (Clinic)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Clinic/Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Ruane Clinical Research Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Stanford Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California, Davis Medical Center (study visits)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sutter Pacific Medical Foundation - California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
University of California, San Francisco Liver Clinic
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Cedars Sinai Medical Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Colorado Denver and Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
48109
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Schiff Center for Liver Diseases/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Advanced Research Institute, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern Memorial Hospital; Clinical Research Unit
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center (outpatient clinic)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University Healthsystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NECCR PrimaCare Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Michigan Medicine - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Gastroenterology, PA
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Southern Therapy and Advanced Research LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Saint Louis University, Gastroenterology & Hepatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Rutgers New Jersey Medical School - Doctors Office Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Northwell Health Center for Liver Diseases and Transplantation
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Center for Liver Disease and Transplantation, Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center - Center for Liver Disease
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Holmes Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Rapid City Medical Center, LLP
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt University Medical Center - Digestive Disease Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor Scott & White Medical Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Spring Gastroenterology Associates
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
San Antonio Military Medical Center, Gastro/Hepatology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Intermountain Medical Center - Transplant Services
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Verity Research Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Bon Secours Richmond Community Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Commonwealth University Clinical Research Services Unit
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Coral Sea Clinical Research Institute - Mackay
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Mater Misericordiae Ltd
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hôpital Erasme - ULB
City
Bruxelles
ZIP/Postal Code
10070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège Site Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
William Osler Health System - Brampton Civic Hospital
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
City
Calgary
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
City
Edmonton
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
City
Halifax
ZIP/Postal Code
B3L 1E4
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
McMaster University Medical Center
City
Hamilton
ZIP/Postal Code
L8S 4L8
Country
Canada
Facility Name
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
City
Montreal
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Chronic Viral Illness Service/McGill University Health Centre (MUHC)
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
University of Manitoba/Health Sciences Centre
City
Winnipeg
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Copenhagen University Hospital - Hvidovre
City
København Ø
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Turku University Hospital, Gastroenterology Outpatient Clinic
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hôpital Saint-Eloi
City
Montpellier cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Amiens-Picardie Hôpital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
City
CHRU Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Grenoble Alpes
City
Grenoble cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Saint-Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU Bordeaux-Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Robert Debré - Centre Hospitalier Universitaire de Reims
City
Reims
ZIP/Postal Code
4025
Country
France
Facility Name
CHU de Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Toulouse Hopital Ranguiel
City
Toulouse cedex
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Toulouse - Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
GASTRO-Studien GbR
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochscule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Gastroenterologisch-Hepatologisches Zentrum Kiel
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsmedizin Mannheim, II. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Emek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
64239
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
62431
Country
Israel
Facility Name
IRCCS Ospedale Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Dipartimento Gastroenterologico e dei Trapianti
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Medicina Interna 1
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedale Universita Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico P. Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Clinico Humanitas - Unita Operativa di Epatologia
City
Rozzano (Milan)
ZIP/Postal Code
20089
Country
Italy
Facility Name
U.O.C. Gatroenterologia
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba-shi
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
ZIP/Postal Code
7008558
Country
Japan
Facility Name
National University Corporation Tohoku University Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
ZIP/Postal Code
173-8606
Country
Japan
Facility Name
Ehime University Hospital
City
Toon-Shi
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
9909585
Country
Japan
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
92103
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Ramon y cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28220
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Clinico Universitario Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitatsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Epatocentro Ticino SA
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
University Hospital Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Aintree University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9NT
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study?nctid=NCT03890120
Description
Related Info

Learn more about this trial

Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis

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