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Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

NCT02951364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1081

Last updated 2021-11-29

No results posted yet for this study

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

  • Hepatitis C Virus

Interventions

DRUG

LDV/SOF

90/400 mg tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2021-06-11
Completion
2021-06-11

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02951364 on ClinicalTrials.gov