drugset / Trial / NCT01710501
A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.
Timeline
- Start
- 2012-12-07
- Primary completion
- 2013-11-25
- Completion
- 2014-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 25 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 50 mg | Oral |
| Subject | GRAZOPREVIR ANHYDROUS | Small molecule | 100 mg | Oral |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 800 mg | Oral |
| Background | Ribavirin | Small molecule | 1400 mg | Oral |