At a glance
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An International, Multicenter, Open-Label Study Evaluating Sustained Virological Response and Safety With Boceprevir in Triple Combination Therapy With Peginterferon Alfa-2a (40KD) and Ribavirin in Treatment-Naïve Patients With Genotype 1 Chronic Hepatitis C
In Brief
A Phase 4 clinical trial evaluating boceprevir, peginterferon alfa-2a [Pegasys], and 1 other intervention for Hepatitis C, Chronic. Completed, enrolled 165 participants across 32 sites in 6 countries.
Detailed Summary
This open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, Pegasys (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. The anticipated time on study treatment is up to 48 weeks.
Study Details
Timeline
Interventions
800 mg three times daily for 24, 32 or 44 weeks
180 mcg subcutaneously once a week for 24, 32 or 44 weeks
180 mcg subcutaneously once a week for 4 weeks
1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
1000 mg or 1200 mg orally once a day for 4 weeks