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

  • STATUS
    Recruiting
  • End date
    Jan 16, 2022
  • participants needed
    3000
  • sponsor
    Gilead Sciences
Updated on 16 August 2021
treatment regimen
chronic hepatitis
sofosbuvir
ledipasvir
ledipasvir/sofosbuvir
harvoni

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.

Details
Condition Hepatitis C, Hepatitis C virus
Treatment LDV/SOF
Clinical Study IdentifierNCT02951364
SponsorGilead Sciences
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals aged 12 years and older who are living in Korea
Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form

Exclusion Criteria

Individuals treated with Harvoni outside of the approved prescribing information in Korea
Individuals who have a contra-indication to Harvoni
Individuals who have a contra-indication to ribavirin
Pregnant or breastfeeding women
Individuals who have previously been administered Harvoni
Individuals participating in a concurrent HCV clinical trial
Individuals planning on leaving the country during the study period
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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