Trials / Completed
CompletedNCT02021656
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 384 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg FDC tablet administered orally once daily without regard to food |
Timeline
- Start date
- 2013-12-10
- Primary completion
- 2017-07-08
- Completion
- 2017-09-29
- First posted
- 2013-12-27
- Last updated
- 2020-03-05
- Results posted
- 2018-12-28
Locations
45 sites across 3 countries: China, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02021656. Inclusion in this directory is not an endorsement.