At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
In Brief
A Phase 2 clinical trial evaluating boceprevir (SCH 503034), peginterferon-alfa 2b (PegIntron), and 2 other interventions for Chronic Hepatitis C. Completed, enrolled 765 participants.
Detailed Summary
This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
Study Details
Timeline
Interventions
200 mg capsules taken as 800 mg orally three times daily (TID)
1.5 μg/kg subcutaneously (SC) once weekly (QW)
200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily