At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
In Brief
A Phase 3 clinical trial evaluating Peginterferon alfa-2b (PEG), Ribavirin (RBV), and 2 other interventions for Hepatitis C, Chronic. Completed, enrolled 1,472 participants.
Detailed Summary
This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone. The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).
Study Details
Timeline
Interventions
Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).
Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID).
Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.