Trials / Completed
CompletedNCT02647632
Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- ANRS, Emerging Infectious Diseases · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to estimate, in HCV genotype 1 or 4-infected patients who failed a prior DAA bitherapy with Sofosbuvir, the efficacy of a treatment with Grazoprevir/Elbasvir, Sofosbuvir and Ribavirin in the two treatment groups and compare the rate of sustained virological response (SVR) 12 weeks after 16 or 24 weeks of this treatment. SVR12 is defined as HCV RNA \< LLOQ (either TD\[u\] or TND).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Grazoprevir/Elbasvir | |
| DRUG | Sofosbuvir | |
| DRUG | Ribavirin |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-01-01
- Completion
- 2017-04-01
- First posted
- 2016-01-06
- Last updated
- 2017-06-29
Source: ClinicalTrials.gov record NCT02647632. Inclusion in this directory is not an endorsement.