Trials / Completed
CompletedNCT02868242
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | Tablet(s) administered orally once daily |
Timeline
- Start date
- 2016-08-28
- Primary completion
- 2018-11-12
- Completion
- 2019-02-03
- First posted
- 2016-08-16
- Last updated
- 2020-03-02
- Results posted
- 2019-08-20
Locations
1 site across 1 country: Egypt
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02868242. Inclusion in this directory is not an endorsement.