Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.

Detailed description:

Arms:
arm 1: Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks. arm 2: Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks. arm 3: Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks. arm 4: Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.

Interventions: intervention 1: Grazoprevir intervention 2: Placebo to Grazoprevir intervention 3: Peginterferon alfa-2b (Peg-IFN) intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: Grazoprevir 100 mg tablets once daily for 12 weeks. intervention 2: Placebo to Grazoprevir once daily for 12 weeks intervention 3: Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks intervention 4: Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks

Protocol document: