Trials / Completed
CompletedNCT02591277
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
A Prospective Observational Post-Marketing Study of Harvoni in Japanese Patients With Genotype 1 Chronic Hepatitis C Infection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,294 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Harvoni | Harvoni (90/400 mg) FDC tablet administered orally once daily |
Timeline
- Start date
- 2015-11-30
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
- First posted
- 2015-10-29
- Last updated
- 2019-02-06
Locations
125 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02591277. Inclusion in this directory is not an endorsement.