Trials / Completed
CompletedNCT01851330
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 647 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily |
| DRUG | RBV | Ribavirin (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
- 2013-05-01
- Primary completion
- 2013-12-01
- Completion
- 2014-03-01
- First posted
- 2013-05-10
- Last updated
- 2018-11-16
- Results posted
- 2014-12-30
Locations
52 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01851330. Inclusion in this directory is not an endorsement.