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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01466790
• Date of registration: 03/11/2011
• Primary sponsor: Janssen R&D Ireland
• Public title: 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 COSMOS
• Scientific title: An Exploratory Phase IIa, Randomized, Open-Label Trial to Investigate the Efficacy and Safety of 12 Weeks or 24 Weeks of TMC435 in Combination With PSI-7977 (GS7977) With Or Without Ribavirin in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Subjects
• Date of first enrolment: January 2012
• Target sample size: 168
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01466790
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Janssen R&D Ireland Clinical Trial
• Affiliation: Janssen R&D Ireland

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: PSI-7977 (GS7977)

Drug: Ribavirin

Drug: TMC435

Primary Outcome(s)

Number of patients with a sustained virologic response (SVR) 12 Weeks after the planned end of treatment [Time Frame: Week 24 (for the 12 Week treatment duration) and Week 36 (for the 24 Week treatment duration)]

Secondary Outcome(s)

Number of patients with a SVR 4 Weeks after the planned end of treatment [Time Frame: Week 16 (for the 12 Week treatment duration) and Week 28 (for the 24 Week treatment duration)]

Number of patients with a SVR at Week 48 [Time Frame: Week 48]

Number of patients with adverse events [Time Frame: Up to Week 48]

Number of patients with inadequate virologic response [Time Frame: Week -6, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48]

Number of patients with undetectable HCV RNA [Time Frame: Week -6, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48]

Number of patients with viral breakthrough [Time Frame: Week -6, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48]

Number of patients with viral relapse [Time Frame: Week -6, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 20, Week 22, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48]

Secondary ID(s)

CR018724

TMC435HPC2002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gilead Sciences