drugset / Trial / NCT01852604
Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)
RandomizedParallel-groupDouble-blindTreatment
Summary
Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
Timeline
- Start
- 2013-03
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 200 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 80 mg/ml | Oral |
| Subject | Samatasvir | Small molecule | 25 mg | Oral |
| Subject | Samatasvir | Small molecule | 50 mg | Oral |
| Subject | Samatasvir | Small molecule | 100 mg | Oral |
| Subject | Samatasvir | Small molecule | 150 mg | Oral |
| Subject | Simeprevir | Small molecule | 75 mg | Oral |
| Subject | Simeprevir | Small molecule | 150 mg | Oral |
| Subject | TMC647055 | Small molecule | 150 mg | Oral |
| Background | Peginterferon alfa-2a | Protein / enzyme biologic | — | Subcutaneous |