Trials / Completed
CompletedNCT02251717
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg FDC tablet administered orally once daily |
Timeline
- Start date
- 2014-10-14
- Primary completion
- 2016-03-24
- Completion
- 2016-06-16
- First posted
- 2014-09-29
- Last updated
- 2018-11-19
- Results posted
- 2017-11-17
Locations
5 sites across 4 countries: Austria, France, Germany, Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02251717. Inclusion in this directory is not an endorsement.