At a glance
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A Single-Arm Study to Provide Boceprevir Treatment in Subjects With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies
In Brief
A Phase 3 clinical trial evaluating Boceprevir, Peginterferon alfa-2b (SCH 54031), and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 168 participants.
Detailed 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.
Study Details
Timeline
Interventions
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).