Status:
COMPLETED
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
Lead Sponsor:
Janssen R&D Ireland
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 viru...
Detailed Description
This is a Phase IIa, randomized (the study medications are assigned by chance), open label (all people know the identity of the intervention) study of TMC435 plus PSI-7977 (GS7977) with or without rib...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01466790
Start Date
January 1 2012
End Date
January 1 2014
Last Update
February 9 2015
Active Locations (23)
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1
Hoover, Alabama, United States
2
Bakersfield, California, United States
3
La Jolla, California, United States
4
San Diego, California, United States