Trials / Completed
CompletedNCT02226549
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | LDV/SOF (90/400 mg) FDC tablet administered orally once daily |
| DRUG | VDV | VDV 80 mg tablet administered orally once daily |
| DRUG | RBV | 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
- 2014-07-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2014-08-27
- Last updated
- 2018-11-16
- Results posted
- 2016-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02226549. Inclusion in this directory is not an endorsement.