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

Condition(s) targeted: Hepatitis C

Intervention: TMC435 (Drug); PSI-7977 (GS7977) (Drug); Ribavirin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Janssen R&D Ireland

Official(s) and/or principal investigator(s):
Janssen R&D Ireland Clinical Trial, Study Director, Affiliation: Janssen R&D Ireland

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

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).

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients with a sustained virologic response (SVR) 12 Weeks after the planned end of treatment

Secondary outcome:

Number of patients with a SVR 4 Weeks after the planned end of treatment

Number of patients with a SVR at Week 48

Number of patients with undetectable HCV RNA

Number of patients with viral breakthrough

Number of patients with inadequate virologic response

Number of patients with viral relapse

Number of patients with adverse events

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 ribavirin. The study consists of a screening phase (6 weeks); a treatment phase (12 or 24 week period); and a posttreatment phase (follow-up period up to Week 48). Approximately 180 patients will be enrolled in this study. Patients will be sequentially enrolled into two cohorts in this study. Cohort 1 (90 patients) will include patients without advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy and Cohort 2 (90 patients) will include only patients with advanced hepatic fibrosis who did not respond to previous PegIFN/ribavirin therapy or are HCV treatment-naive. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The entire study duration for each participant will be approximately 48 weeks.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Santurce, Puerto Rico; Recruiting

Birmingham, Alabama, United States; Not yet recruiting

Hoover, Alabama, United States; Completed

Bakersfield, California, United States; Active, not recruiting

La Jolla, California, United States; Recruiting

San Diego, California, United States; Recruiting

New Haven, Connecticut, United States; Recruiting

Brandenton, Florida, United States; Recruiting

Jacksonville, Florida, United States; Recruiting

Orlando, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

Wellington, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Lutherville, Maryland, United States; Recruiting

Lebanon, New Hampshire, United States; Recruiting

New York, New York, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Arlington, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

San Antonio, Texas, United States; Recruiting

Falls Church, Virginia, United States; Active, not recruiting

Norfolk, Virginia, United States; Recruiting

Seatle, Washington, United States; Recruiting

Seattle, Washington, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: January 2012
Last updated: February 1, 2013