Trials / Completed
CompletedNCT02613871
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg FDC tablet administered orally once daily |
Timeline
- Start date
- 2015-12-22
- Primary completion
- 2017-01-04
- Completion
- 2018-11-07
- First posted
- 2015-11-25
- Last updated
- 2020-03-06
- Results posted
- 2018-02-13
Locations
8 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02613871. Inclusion in this directory is not an endorsement.