Trials / Completed
CompletedNCT02472886
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg FDC tablet administered orally once daily |
| DRUG | RBV | Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Timeline
- Start date
- 2015-06-17
- Primary completion
- 2016-03-30
- Completion
- 2016-06-30
- First posted
- 2015-06-16
- Last updated
- 2018-11-16
- Results posted
- 2017-05-10
Locations
20 sites across 2 countries: Estonia, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02472886. Inclusion in this directory is not an endorsement.