Conditions: Hepatitis C, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 168
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous protocol received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Interventions: intervention 1: Boceprevir intervention 2: Peginterferon alfa-2b (SCH 54031) intervention 3: Ribavirin (SCH 18908)
Intervention descriptions: intervention 1: Boceprevir, 200-mg capsules, 800 mg three times a day (TID) orally (PO) intervention 2: Peginterferon alfa-2b 1.5 µg/kg/week subcutaneously (SC) intervention 3: Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).

Protocol document: