A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: BI 201335; PegIFN/RBV
Intervention description: BI 201335 for 24 weeks; PegIFN/RBV for 48 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of
      treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon
      (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from
      PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.
    

Eligibility criteria:

        Inclusion criteria:

        Chronic hepatitis C infection of GT-1 in patients who failed prior treatment with PegIFN
        and RBV in the 1220.7, 1220.30 and 1220.47 trials of the BI 201335 Phase III program.

          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 device and cervical cap.

             or

             Male patients:

               -  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.

        Exclusion criteria:

          1. Evidence of acute or chronic liver disease due to causes other than chronic HCV
             infection. Incidental steatosis diagnosed by biopsy is not an exclusion criteria.

          2. HIV co-infection

          3. Hepatitis B virus (HBV) infection based on presence of HBs-Ag

          4. Active malignancy, or history of malignancy within the last 5 years prior to screening
             (with an exception of appropriately treated basal cell carcinoma of the skin or in
             situ carcinoma of the uterine cervix)

          5. Active or, history of alcohol or illicit drug abuse other than cannabis within the
             past 12 months

          6. A condition that is defined as one which in the opinion of investigator may put the
             patient at risk because of participation in this study, may influence the results of
             this study, or limit the patients ability to participate in this study

          7. Usage of any investigational drugs within 30 days prior to screening, or planned usage
             of an investigational drug during the course of this study.

          8. Received concomitant systemic antiviral, hematopoietic growth factor, or
             immunomodulatory treatment within 30 days prior to screening. Patients being treated
             with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent
             herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection,
             may be screened.

          9. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days
             prior to enrolment and throughout the treatment phase of this trial.

         10. Known hypersensitivity to any ingredient of the study drugs.

         11. Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL,
             patients may be included if there is no evidence of liver cancer in an appropriate
             imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to
             randomization (Visit 2).

        Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are
        not listed here.