Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2005-09-01
The primary objective of this study is to determine the safe and effective dose range of
boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic
hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy
with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin
provides an additional benefit when combined with PEG-Intron plus boceprevir.
Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2007-01-01
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.
Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
Terminated
Merck Sharp & Dohme Corp.
Phase 2/Phase 3
2007-02-20
Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated
with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants
will be followed for up to 3.5 years after the end of their participation in the treatment
protocol to document maintenance of the antiviral response (for sustained responders) and to
characterize the long-term safety after use of this therapeutic regimen. LTFU procedures
include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid
(HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will
be administered as part of this study.
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