Trials / Completed
CompletedNCT03036839
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg fixed- dose combination (FDC) tablet administered orally once daily |
Timeline
- Start date
- 2017-06-27
- Primary completion
- 2018-11-22
- Completion
- 2019-02-14
- First posted
- 2017-01-30
- Last updated
- 2020-03-02
- Results posted
- 2019-12-09
Locations
21 sites across 5 countries: United States, Belgium, Germany, Italy, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03036839. Inclusion in this directory is not an endorsement.