Trials / Completed
CompletedNCT02951364
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,081 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LDV/SOF | 90/400 mg tablet administered orally once daily |
Timeline
- Start date
- 2016-12-05
- Primary completion
- 2021-06-11
- Completion
- 2021-06-11
- First posted
- 2016-11-01
- Last updated
- 2021-11-29
Locations
72 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02951364. Inclusion in this directory is not an endorsement.