NCT00708500

Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)

A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (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 pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA \[HCV-RNA\] viral load \>=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Boceprevir (SCH 503034)	Boceprevir, 200 mg capsules, 800 mg TID PO
BIOLOGICAL	Pegylated interferon alfa-2b (SCH 54031)	PEG2b 1.5 μg/kg/week subcutaneously (SC)
DRUG	Ribavirin (SCH 18908)	Ribavirin WBD 600 mg/day to 1400 mg/day by mouth (PO) divided twice daily (BID).
DRUG	Boceprevir placebo	Boceprevir placebo, 200 mg capsules, 800 mg three times daily (TID) PO.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-07-02
• Last updated: 2017-04-07
• Results posted: 2011-06-15