drugset / Trial / NCT01366638
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser or non-responder to Interferon-based therapy) in Japan.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-11
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simeprevir | Small molecule | 100 mg | Oral |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 600 mg | Oral |
| Background | Ribavirin | Small molecule | 800 mg | Oral |
| Background | Ribavirin | Small molecule | 1000 mg | Oral |