drugset / Trial / NCT01288209
A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan.
Timeline
- Start
- 2011-02
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simeprevir | Small molecule | 100 mg | Oral |
| Background | Peginterferon alfa-2a (PegIFNα-2a ) | Unknown | 180 ug | Subcutaneous |
| Background | Ribavirin (RBV) | Unknown | 200 mg | Oral |
| Background | Ribavirin (RBV) | Unknown | 400 mg | Oral |
| Background | Ribavirin (RBV) | Unknown | 600 mg | Oral |