A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

January 31, 2014

Conditions
Hepatitis C
Interventions
DRUG

TMC435

TMC435 will be administered as one oral capsule of 150 mg once a day.

DRUG

PSI-7977 (GS7977)

PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.

DRUG

Ribavirin

Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).

Trial Locations (23)

Unknown

Hoover

Bakersfield

La Jolla

San Diego

New Haven

Brandenton

Jacksonville

Orlando

Tampa

Wellington

Atlanta

Chicago

Lutherville

Lebanon

New York

Pittsburgh

Arlington

Dallas

San Antonio

Falls Church

Norfolk

Seatle

Santurce

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Janssen R&D Ireland

INDUSTRY

NCT01466790 - A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients | Biotech Hunter | Biotech Hunter