Clinical trial NCT00423670
Conditions: Chronic Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-01-01; Completion date: 2008-11-01
Enrollment: 765 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Participants treated with PegIntron (1.5 μg/kg, once weekly \[QW\]) and Ribavirin (800 to 1400 mg/day) for 48 weeks.

Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and boceprevir (800 mg three times daily \[TID\]) for 24 additional weeks. The participants that crossed over to receive boceprevir formed Arm 8. The total treatment duration was up to 54 weeks. arm 2: Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks. arm 3: Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks. arm 4: Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks. arm 5: Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks. arm 6: Participants receiving PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks during Part II of the study. Part II was initiated after participants were fully enrolled for Part I. arm 7: Participants receiving PegIntron (1.5 μg/kg QW), low-dose ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks (Arm 7) during Part II of the study. Part II was initiated after participants were fully enrolled for Part I. arm 8: Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with

PegIntron (1.5 μg/kg QW), and ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
Interventions: intervention 1: boceprevir (SCH 503034) intervention 2: peginterferon-alfa 2b (PegIntron) intervention 3: ribavirin intervention 4: ribavirin (low-dose)
Intervention descriptions: intervention 1: 200 mg capsules taken as 800 mg orally three times daily (TID) intervention 2: 1.5 μg/kg subcutaneously (SC) once weekly (QW) intervention 3: 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily intervention 4: 200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily

Protocol documents: