Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

June 8, 2015

Primary Completion Date

October 11, 2016

Study Completion Date

October 11, 2016

Conditions
Non-Alcoholic Steatohepatitis (NASH)
Interventions
DRUG

SEL

SEL tablet administered orally once daily

BIOLOGICAL

SIM

Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly

Trial Locations (28)

15143

University of Pittsburg Medical Center, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

22908

University of Virginia, Charlottesville

23226

St. Mary's Hospital, Richmond

23298

Virginia Commonwealth University Health System, Richmond

23602

Mary Immaculate Hospital, Newport News

46202

Indiana University School of Medicine, Indianapolis

60611

Northwestern University, Chicago

64131

Kansas City Research Institute, Kansas City

75203

Methodist Dallas Medical Center, Dallas

76012

Texas Clinical Research Institute, Arlington

77030

CHI St. Luke's Health Baylor College of Medicine, Houston

78215

American Research Corporation at Texas Liver Institute, San Antonio

78233

Digestive Research Center, Live Oak

78234

Brooke Army Medical Center Ft. Sam, Houston

80045

University of Colorado Denver, Aurora

84107

Intermountain Medical Center, Murray

92103

University of California San Diego, San Diego

94143

University of California San Francisco, San Francisco

94304

Stanford University Medical Center, Palo Alto

98104

Swedish Medical Center, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

03125

Duke University Medical Center, Durham

T2N4Z6

University of Calgary, Calgary

M6H 3M1

Toronto Liver Centre, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY