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Trial record 25 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

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

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ClinicalTrials.gov Identifier: NCT02951364
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Virus Drug: LDV/SOF

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LDV/SOF
Adult Korean participants and pediatric Korean participants aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
Drug: LDV/SOF
90/400 mg tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) [ Time Frame: Up to 30 days following treatment ]
    Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.

  2. Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA < lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as "improved/success" when HCV RNA < LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) [ Time Frame: Up to Posttreatment Week 12 ]
    Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult Korean individuals and pediatric Korean individuals aged 12 to <18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
Criteria

Key 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

Key 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951364


Contacts
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Contact: Gilead Study Team GS-US-337-1966@gilead.com

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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02951364     History of Changes
Other Study ID Numbers: GS-US-337-1966
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
observational
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents