NCT00705432

Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)

A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,472 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b (PEG)	Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
DRUG	Ribavirin (RBV)	Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).
DRUG	Placebo	Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID).
DRUG	Boceprevir	Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-06-26
• Last updated: 2017-04-07
• Results posted: 2011-06-14