Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Boceprevir; Peginterferon alfa-2b (SCH 54031); Ribavirin (SCH 18908)
Intervention description: Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO); Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC); Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon
      plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who
      completed their per-protocol defined treatment and did not achieve sustained viral response
      (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI)
      study of BOC combination therapy. Participants who are able to enroll in this study within 2
      weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up
      to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to
      enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are
      to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks
      post-treatment follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have been assigned to a PEG/RBV control arm in a previous SPRI study
             of BOC, must have completed treatment as per protocol, and have been compliant with
             all study treatment and scheduled procedures within the previous study.

          -  Participant must have received at least 12 weeks of treatment with PEG/RBV and must
             have discontinued treatment in the previous study due to the futility rule (as defined
             in the previous protocol), had virologic breakthrough, or relapse.

          -  Participant must have had detectable HCV-RNA upon completion of the previous study.

          -  Participant and participant partner(s) must each agree to use acceptable methods of
             contraception for at least 2 weeks prior to starting any study treatment and to
             continue until at least 6 months after the last doses of study drugs, or longer if
             dictated by local regulations.

          -  Participant must be willing to give written informed consent.

        Exclusion Criteria:

          -  All participant exclusion criteria from the SPRI clinical study in which the
             participant participated prior to qualifying for this study will apply in this study,
             EXCEPT for the following:

               -  Treatment with RBV within 90 days and any interferon-alpha within 1 month of the
                  enrollment is not exclusionary in P05514.

               -  Participation in any other SPRI clinical trial within 30 days of enrollment in
                  this study is not exclusionary.

               -  Use of growth factor at the entry of the study is allowed if it was prescribed in
                  the previous study.

               -  Laboratory criteria of thyroid-stimulating hormone (TSH) do not apply. Laboratory
                  criteria of hemoglobin, neutrophils, and platelets do not apply, unless they met
                  dose reduction/interruption/discontinuation criteria in the previous study.

               -  Participants who develop moderate depression in the previous study and continue
                  to be stable and well controlled are not excluded

          -  Participants who had the opportunity to receive boceprevir in the previous study.

          -  Participants requiring discontinuation, interruption, or dose reduction of RBV for
             more than 2 weeks in the previous study.

          -  Participants requiring discontinuation, interruption, or dose reduction of PEG to less
             than two-thirds of the assigned starting dose for more than 2 weeks in the previous
             study.

          -  Participants who experienced a life-threatening SAE considered at least possibly
             related to study drugs by the investigator or sponsor in the previous study.