NCT00423670

Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)

A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 765 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study was conducted in 2 parts. Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared: * PegIntron and ribavirin for 48 weeks (Arm 1 - Control) * PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2) * Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and boceprevir for 24 weeks (Arm 3) * PegIntron, ribavirin and boceprevir for 48 weeks (Arm 4) * Lead-in with PegIntron and ribavirin for 4 weeks, followed by PegIntron, ribavirin and boceprevir for 44 weeks (Arm 5) Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks. All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm (Arm 8). Part 2 of the study assessed the safety and efficacy of low dose ribavirin (400-1000 mg/day) and compared: * PegIntron, ribavirin (800-1400 mg/day) and boceprevir for 48 weeks (Arm 6) * PegIntron, low-dose ribavirin (400-1000 mg/day) and boceprevir for 48 weeks (Arm 7) Follow-up for all participants was up to 72 weeks after randomization.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	boceprevir (SCH 503034)	200 mg capsules taken as 800 mg orally three times daily (TID)
DRUG	peginterferon-alfa 2b (PegIntron)	1.5 μg/kg subcutaneously (SC) once weekly (QW)
DRUG	ribavirin	200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily
DRUG	ribavirin (low-dose)	200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-08-01
• Completion: 2008-11-01
• First posted: 2007-01-18
• Last updated: 2017-04-05
• Results posted: 2011-06-15