Trials / Completed
CompletedNCT02350569
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg FDC tablet administered orally |
Timeline
- Start date
- 2015-05-22
- Primary completion
- 2016-03-28
- Completion
- 2016-04-22
- First posted
- 2015-01-29
- Last updated
- 2018-11-19
- Results posted
- 2017-05-05
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02350569. Inclusion in this directory is not an endorsement.