Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

PHASE2CompletedINTERVENTIONAL
Enrollment

395

Participants

Timeline

Start Date

March 21, 2018

Primary Completion Date

October 30, 2019

Study Completion Date

November 19, 2019

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

SEL

18 mg tablet administered orally once daily without regard to food

DRUG

FIR

20 mg tablet administered orally once daily without regard to food

DRUG

CILO

30 mg tablet administered orally once daily without regard to food

DRUG

Placebo to match FIR

Tablet administered orally once daily without regard to food

DRUG

Placebo to match CILO

Tablet administered orally once daily without regard to food

DRUG

Placebo to match SEL

Tablet administered orally once daily without regard to food

Trial Locations (101)

1023

Auckland City Hospital, Auckland

2010

St Vincent's Hospital Sydney, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

3004

The Alfred Hospital, Alfred Health, Melbourne

3050

Melbourne Health, Royal Melbourne Hospital, Parkville

3065

St Vincent's Hospital Melbourne, Fitzroy

3084

Austin Health, Heidelberg

3168

Monash Health, Monash Medical Centre, Clayton

4029

Royal Brisbane & Women's Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

10003

Icahn School of Medicine at Mount Sinai Beth Israel, New York

10016

Concorde Medical Group, PLLC, New York

NYU Langone Health, New York

10021

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10467

Montefiore Medical Center, The Bronx

11030

Sandra Atlas Bass Center for Liver Diseases and Transplantation, Manhasset

15213

UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute, Pittsburgh

15240

VA Pittsburgh Healthcare System, Pittsburgh

19104

Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21202

Mercy Medical Center, Baltimore

21228

Digestive Disease Associates, PA, Catonsville

22042

California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant, Falls Church

22908

University of Virginia Medical Center, Charlottesville

23226

Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond, Richmond

23249

McGuire DVAMC, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

27710

Duke University Medical Center, Duke South Clinics, Durham

28204

Carolinas Healthcare System Center for Liver Disease and Transplant, Charlotte

28304

Cumberland Research Associates, LLC, Fayetteville

29425

Medical University of South Carolina (Liver Biopsy), Charleston

29605

GHS Gastroenterology and Liver Center, Greenville

30060

Gastrointestinal Specialists of Georgia, Marietta

30309

Digestive Healthcare of Georgia, Atlanta

Piedmont Hospital, Atlanta

31904

Gastrointestinal Diseases Research, Columbus

32610

UF Hepatology Research at CTRB, Gainesville

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33157

IMIC Inc, Miami

33165

Genoma Research Group, Miami

33166

Integrity Clinical Research, Doral

34211

Florida Research Institute, Tampa

37211

Quality Medical Research, PLLC, Nashville

38138

Gastro One, Germantown

39157

Southern Therapy and Advanced Research (STAR) LLC, Ridgeland

45249

Consultants for Clinical Research wed, Cincinnati

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48202

Henry Ford Health Systems, Detroit

50325

Iowa Digestive Disease Center, P.C., Clive

55905

Mayo Clinic, Rochester

60611

Northwestern University; Feinberg School of Medicine, Chicago

63110

Saint Louis University, St Louis

64111

Saint Luke's Hospital of Kansas City, Kansas City

66160

University of Kansas Medical Center, Kansas City

70112

Tulane University, New Orleans

71105

Louisiana Research Center, LLC, Shreveport

71220

Delta Research Partners, LLC, Bastrop

72117

Arkansas Gastroenterology, North Little Rock

72204

Liver Wellness Center, Little Rock

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75390

University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials, Dallas

76012

Texas Clinical Research Institute, LLC, Arlington

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

Houston Methodist Hospital, Houston

78215

American Research Corporation at Texas Liver Institute, San Antonio

78233

Pinnacle Clinical Research, Live Oak

78746

Pinnacle Clinical Research, PLLC, Austin

78758

Austin Center for Clinical Research, Austin

80113

South Denver Gastroenterology, PC, Englewood

84107

Intermountain Liver Disease and Transplant Center, Murray

84132

University of Utah Hospital, Salt Lake City

85054

Mayo Clinic Arizona, Mayo Clinic Hospital, Phoenix

89106

Jubilee Clinical Research, Inc., Las Vegas

90036

Ruane Clinical Research Group Inc., Los Angeles

91105

California Liver Research Institute, Pasadena

Huntington Medical Research Institutes Liver Center, Pasadena

92037

UCSD NAFLD Clinical Research Center, La Jolla

92118

Southern California Liver Center, Coronado

92123

Medical Associates Research Group, San Diego

92377

Inland Empire Liver Foundation, Rialto

93720

Fresno Clinical Research Center, Fresno

95817

University of California, Davis Medical Center (study visits), Sacramento

98101

Virginia Mason Medical Center, Seattle

98104

Swedish Organ Transplant and Liver Center, Seattle

99352

Cedars-Sinai Medical Center, Los Angeles

85224-5688

The Institute for Liver Health, Chandler

91911-6660

eStudySite, Chula Vista

02215

Beth Israel Deaconess Medical Center, Boston

07103

Rutgers New Jersey Medical School- Doctors Office Center, Newark

02905

University Gastroenterology, Providence

L6R 3J7

William Osler Health System-Brampton Civic Hospital, Brampton

T2N 4Z6

University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary

H4A 3J1

Chronic Viral Illness Service McGill University Health Centre (MUHC)/ Royal Victoria Hospital, Montreal

M5G 2C4

Toronto General Hospital, Toronto

M6H 3M1

Toronto Liver Centre, Toronto

Unknown

Prince of Wales Hospital, Shatin

00927

Fundacion de Investigacion de Diego, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY