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

November 24, 2021 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1081

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang-si, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon-si, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Bucheon-si, Korea, Republic of, 14647
        • The Catholic University of Korea Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 614-735
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of
        • Busan Veterans Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Medical Center
      • Busan, Korea, Republic of, 48094
        • Bumin Hospital Haeundae
      • Busan, Korea, Republic of, 48265
        • Good Gang-An Hospital
      • Busan, Korea, Republic of
        • Busan St. Mary's Hospital
      • Busan, Korea, Republic of
        • Maryknoll Medical Center
      • Changwon, Korea, Republic of, 51394
        • Changwon Fatima Hospital
      • Cheonan, Korea, Republic of, 31116
        • Dankook University Hospital
      • Cheonan, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
      • Chuncheon-si, Korea, Republic of, 24253
        • Hallym University Chuncheon Sacred Heart Hospital
      • Chungju-si, Korea, Republic of
        • Konkuk University Chungju hospital
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook national university medical center Chil-Gok
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Gangneung-si, Korea, Republic of
        • Gangneung Asan Hospital
      • Goyang, Korea, Republic of, 10475
        • MyongJi Hospital
      • Goyang, Korea, Republic of, 10326
        • Dongguk University Ilsan Hospital
      • Goyang-si, Korea, Republic of, 10444
        • National Health Insurance Corporation Ilsan Hospital
      • Gumi, Korea, Republic of, 39295
        • Kumi Cha Hospital
      • Gwangju, Korea, Republic of, 501-717
        • Chosun University Hospital
      • Gwangju, Korea, Republic of
        • Kwangju Christian Hospital
      • Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
      • Gyeongju-si, Korea, Republic of
        • Dongguk University Gyeongju Hospital
      • Hwaseong-si, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Iksan, Korea, Republic of, 54538
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Jeju-si, Korea, Republic of, 63127
        • Cheju Halla General Hospital
      • Jeonju, Korea, Republic of, 54987
        • Presbyterian Medical Center
      • Jeonju-si, Korea, Republic of
        • Chonbuk National University Hospital
      • Jinju-si, Korea, Republic of, 660-702
        • Gyeongsang National University Hospital
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Eulji General Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 07061
        • SMG - SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 100-032
        • Inje University Seoul Paik Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Hospital
      • Seoul, Korea, Republic of, 03830
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of, 05535
        • Kangdong Sacred Heart Hospital
      • Suwon-si, Korea, Republic of, 41931
        • The Catholic University of Korea, St. Vincent's Hospital
      • Uijeongbu-si, Korea, Republic of
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Ulsan, Korea, Republic of, 44455
        • Dongkang Hospital
      • Ulsan, Korea, Republic of, 44686
        • Ulsan Hospital
      • Wonju-si, Korea, Republic of, 49201
        • Yonsei University Wonju Severance Christian Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13496
        • CHA Bundang Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 30 days following treatment
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.
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Posttreatment Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 5, 2016

Primary Completion (ACTUAL)

June 11, 2021

Study Completion (ACTUAL)

June 11, 2021

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-337-1966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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