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A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis (STREAGER)
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis The primary objectives of this study are as follows: * To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12). * To evaluate the safety and tolerability of EBV/GZR treatment The secondary objectives of this study are as follows: * To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) * To evaluate the proportion of subjects with virologic failure * To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment. * To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment
Details
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 117 |
| Start date | 2017-01-11 |
| Completion | 2019-04 |
Conditions
- Chronic HCV Infection
Interventions
- Elbasvir/Grazoprevir Fixed Dose Combination
Primary outcomes
- Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12). — at 12 weeks post-treatment
Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests
Countries
France