NCT01435044 - Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection | Biotech Hunter

Enrollment

239

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

Conditions

Hepatitis C, Chronic

Interventions

DRUG

Sofosbuvir

Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

DRUG

GS-0938

GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

Placebo to match sofosbuvir

Placebo to match sofosbuvir administered orally once daily

DRUG

Placebo to match GS-0938

Placebo to match GS-0938 administered orally once daily

Trial Locations (44)

10016

Concorde Medical Group, New York

10029

Mount Sinai Medical Center, New York

20009

Washington D.C.

21229

Baltimore

21401

Investigative Clinical Research, Annapolis

23502

Digestive and Liver Disease Specialists, Norfolk

27103

Digestive Health Specialists, Winston-Salem

28677

Carolina's Center for Liver Disease, Statesville

28801

Ashville Gastroenterology Associates, Ashville

30060

Marietta

30308

AIDS Research Consortium of Atlanta, Atlanta

Atlanta

32610

University of Florida Hepatology, Gainesville

32720

Avail Clinical Research, DeLand

32803

Orlando Immunology Center, Orlando

32806

Internal Medicine Specialists, Orlando

33136

University of Miami Center for Liver Diseases, Miami

33143

Miami Research Associates, South Miami

33414

South Florida Center of Gastroenterology, Wellington

34655

Advanced Research Institute, Trinity

36116

Alabama Liver & Digestive Specialists, Montgomery

37211

Nashville Gastrointestinal Specialists, Nashville

38138

Gastro One, Germantown

60515

Digestive Health Services, Downers Grove

76012

Texas Clinical Research Institute, Arlington

78215

Alamo Medical Research, San Antonio

78705

Central Texas Clinical Research, Austin

80113

Engelwood

South Denver Gastroenterology, Englewood

80220

Denver

90036

Los Angeles

90048

CLI, Los Angeles

91942

La Mesa

92103

UCSD Antiviral Research Center, San Diego

92118

Coronado

92120

eStudy Site, San Diego

92193

Medical Associates Research Group, San Diego

93301

Bakersfield

94115

Quest Clinical Research, San Francisco

98101

Virginia Mason Medical Center, Seattle

08844

ID Care, Hillsborough

Unknown

Cincinnati

00909

San Juan

00927

Fundacion de Investigacion de Diego, San Juan