Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

PHASE3CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

April 30, 2015

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.

DRUG

Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2

DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.

DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.

Trial Locations (40)

Unknown

Dothan

Bakersfield

Chula Vista

Los Angeles

San Diego

Englewood

Bradenton

Jacksonville

Lauderdale Lakes

Maitland

Miami

Orlando

Wellington

Zephyrhills

Atlanta

Columbus

Marietta

Indianapolis

Jackson

Kansas City

Hillsborough

Vineland

Manhasset

New York

Asheville

Winston-Salem

Pittsburgh

East Greenwich

Providence

Greer

Germantown

Knoxville

Nashville

Arlington

Austin

San Antonio

Falls Church

Norfolk

Vancouver

Montreal

All Listed Sponsors
lead

Janssen Infectious Diseases BVBA

INDUSTRY

NCT02114177 - Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis | Biotech Hunter | Biotech Hunter