Safety, Tolerability, and Antiviral Activity of 24 or 48 Weeks of GS-9190 in Combination With Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

July 31, 2009

Study Completion Date

September 30, 2013

Conditions
HCV Infection
Interventions
DRUG

placebo

oral BID

DRUG

GS-9190

40 mg oral BID

DRUG

Peginterferon Alfa 2a

All subjects received a fixed dose of 180 μg PEG via subcutaneous injection on a weekly basis.

DRUG

Ribavirin

Ribavirin supplied as 200 mg Copegus® tablets (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) were given in a divided daily dose.

Trial Locations (72)

8

Dublin

9

Dublin

10016

New York

10021

New York

10032

New York

10969

Berlin

11803

Plainview

13210

Syracuse

13790

Johnson City

19104

Philadelphia

19140

Philadelphia

20099

Hamburg

21201

Baltimore

21229

Baltimore

21287

Baltimore

22031

Fairfax

23298

Richmond

27262

High Point

27710

Durham

28801

Asheville

30033

Decatur

30308

Atlanta

30625

Hanover

32803

Orlando

33136

Miami

33162

North Miami Beach

33613

Tampa

34243

Sarasota

38138

Germantown

42101

Bowling Green

45219

Cincinnati

45267

Cincinnati

48202

Detroit

50921

Cologne

60590

Frankfurt

60611

Chicago

63104

St Louis

70809

Baton Rouge

74104

Tulsa

75208

Dallas

77090

Houston

78215

San Antonio

80110

Englewood

80336

München

90048

Los Angeles

92115

San Diego

92123

San Diego

92663

Newport Beach

92673

San Clemente

92801

Anaheim

94115

San Francisco

02114

Boston

07927

Cedar Knolls

10029-6574

New York

22003-6800

Annandale

23502-3927

Norfolk

B-1070

Brussels

B-1200

Brussels

B-9000

Ghent

Unknown

Leuven

Liège

Dublin

Chorzów

London

15-540

Bialystok

85-030

Bydgoszcz

41-250

Czeladź

31-501

Krakow

01-201

Warsaw

00909

Santurce

B15 2TH

Birmingham

E1 1BB

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00743795 - Safety, Tolerability, and Antiviral Activity of 24 or 48 Weeks of GS-9190 in Combination With Peginterferon Alfa 2a and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection | Biotech Hunter | Biotech Hunter