drugset / Trial / NCT02204475
Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, multi-site, open-label trial of a fixed-dose combination of Grazoprevir (MK-5172) and Elbasvir (MK-8742) versus Boceprevir (BOC) / Pegylated Interferon (P) and Ribavirin (R) in treatment-naive and prior treatment failure genotype (GT) 1 hepatitis C virus (HCV)-infected participants. The primary hypothesis is that the proportion of treatment-naive (TN) and prior treatment failure (PTF) participants treated with grazoprevir + elbasvir achieving sustained virologic response (undetectable HCV ribonucleic acid \[RNA\]) 12 weeks after the end of study therapy (SVR12) will be greater than the proportion of BOC/PR-treated participants achieving SVR12.
Timeline
- Start
- 2014-11
- Primary completion
- 2016-06
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Boceprevir | Small molecule | 800 mg | Oral |
| Subject | Elbasvir | Small molecule | 50 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 100 mg | Oral |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Comparator | Ribavirin | Small molecule | 800 mg | Oral |
| Comparator | Ribavirin | Small molecule | 1400 mg | Oral |