Trials / Completed
CompletedNCT02487030
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 255 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 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 based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Timeline
- Start date
- 2015-09-07
- Primary completion
- 2016-11-11
- Completion
- 2017-02-04
- First posted
- 2015-07-01
- Last updated
- 2018-11-16
- Results posted
- 2017-12-14
Locations
4 sites across 1 country: Egypt
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02487030. Inclusion in this directory is not an endorsement.