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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).

Key facts

Study ID

NCT01466790

Run by

Janssen R&D Ireland

People needed

168

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-02-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic genotype 1 hepatitis C virus (HCV) infection
• Plasma HCV RNA of more than 10,000 IU/mL at screening
• Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks
• Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1 documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive weeks and could also be HCV treatment-naive, meaning never received treatment with any approved or investigational drug for the treatment of HCV
• Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA from baseline at Week 12 of the most recent PegIFN/ribavirin therapy
• Patient must have had a liver biopsy within 3 years before screening (or between screening and baseline visit) or patient must have had a liver biopsy at any time in the past which showed Metavir F3 or F4 fibrosis
• Must agree to use 2 forms of effective contraception throughout the study (male and female)

You may not qualify if…

• Has evidence of hepatic decompensation
• Has any liver disease of non-HCV etiology
• Has an infection/co-infection with non-genotype 1 HCV
• Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)
• Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
• Has a history of malignancy within 5 years of the screening visit

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Bakersfield, California, United States
• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Brandenton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Lutherville, Maryland, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — New York, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Arlington, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Falls Church, Virginia, United States
• Study site — Norfolk, Virginia, United States
• Study site — Seatle, Washington, United States
• Study site — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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