Hepatitis C, Chronic Clinical Trial
Official title:
A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
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).
Participants from Cohort I and Cohort II are assigned (randomized) to one of three study
arms, all of which have a 4-week lead-in period with (PEG + RBV).
1. Control arm, participants are treated with (PEG + RBV + placebo) for 44 weeks after the
lead-in.
2. Experimental arm with Response Guided Therapy (RGT)
In this experimental arm, participants are treated with all three drugs (PEG + RBV +
boceprevir) for 24 weeks after the lead-in. At treatment week 28, those participants
with undetectable Hepatitis C Virus - ribonucleic acid (HCV-RNA) from week 8 (up to
treatment week 24), will be considered to complete treatment, and will enter follow-up.
Participants with detectable for HCV-RNA at week 8 or later will receive an additional
20 weeks of therapy with PegIntron and Ribavirin (PEG + RBV + placebo).
3. Experimental arm, participants are treated with all three drugs (PEG + RBV + Ribavirin)
for 44 weeks after the lead-in.
All participants were followed up to 72 weeks following randomization.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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