A phase III, open-label study of once daily BI 201335 240 mg for 24 weeks in combination with pegylated interferon-α (PegIFN) and ribavirin (RBV) in patients with genotype 1 chronic hepatitis C infection who failed a prior PegIFN/RBV treatment
This is a multi-national, open-label trial enrolling into two cohorts. It is planned to include approximately 200 treatment experienced patients who have failed on the placebo arm of the phase III BI 201335 trials with chronic HCV infection of GT-1. Only patients enrolled previously in the BI201335 trials will be eligible.
Patients will be placed into one of two treatment cohorts dependent on the patient[Right Quote]s previous response to treatment:
Group 1: Non-responder (null and partial) and breakthrough patients will receive BI 201335 (240mg once daily) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
Group 2: Relapser patients will receive BI 201335 (240 mg once daily) combined with PegIFN/RBV for 24 weeks.
A total of approximately 200 subjects will be enrolled in this study at approximately 123 centers in North America and Asia with the UT Southwestern Medical Center site enrolling 10 subjects (inclusive of screen failures).
The maximum time that a subject is expected to be enrolled in the study will depend upon their response to treatment. Screening, treatment, and treatment follow-up will require a maximum of 126 weeks.
1. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).
2. Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
3. Female patients:
• with documented hysterectomy,
• who have had both ovaries removed,
• with documented tubal ligation,
• who are post-menopausal with last menstrual period at least 12 months prior to screening, or
• of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after
the last dose of RBV in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV.
Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance intra-uterine
• who are documented to be sterile, or
• who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date
of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and
the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
4. Signed informed consent form prior to trial participation.