A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

October 31, 2013

Conditions
Hepatitis BHBV
Interventions
DRUG

Single Ascending Dose (SAD) Cohorts GS-9620

This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.

DRUG

Multiple Ascending Dose (MAD) Cohorts

This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses)

Trial Locations (23)

1142

Auckland Clinical Studies, Grafton

2747

Nepean Hospital, Kingswood

3168

Monash University, Department of Medicine, Clayton

4029

Royal Brisbane and Women's Hospital, Herston

6009

Royal Perth Hospital, Nedlands

10021

Weill Cornell Medical College, New York

19139

CRI Worldwide, LLC, Philadelphia

44106

University Hospitals Case Medical Center, Cleveland

48202

Henry Ford Health System, Detroit

64131

Kansas City Gastroenterology and Hepatology, Kansas City

70122

Tulane University Health Sciences Center, New Orleans

77030

Baylor College of Medicine, Houston

84123

University of Utah, Salt Lake City

85054

Mayo Clinic Hospital, Phoenix

92103

University of California Antiviral Research Center (AVRC), San Diego

92626

West Coast Clinical Trials, LLC, Costa Mesa

46202-5121

Indiana University Medical Center, Indianapolis

02215

Beth Israel Deaconess Medical Center, Boston

T2N 4Z6

University of Calgary, Heritage Medical Research Center, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

H3P 3P1

Algorithme Pharma, Inc., Montreal

Unknown

Asan Medical Center, Seoul

Seoul National University Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01590641 - A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B | Biotech Hunter | Biotech Hunter