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
1 other identifier
observational
1,081
1 country
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedNovember 29, 2021
November 1, 2021
4.5 years
October 28, 2016
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
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)
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 Outcomes (1)
Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
Up to Posttreatment Week 12
Study Arms (1)
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
Interventions
90/400 mg tablet administered orally once daily
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (72)
CHA Bundang Medical Center
Seongnam-si, Gyeonggido, 13496, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, 14068, South Korea
SoonChunHyang University Bucheon Hospital
Bucheon-si, 14584, South Korea
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, 14647, South Korea
Bumin Hospital Haeundae
Busan, 48094, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Good Gang-An Hospital
Busan, 48265, South Korea
Dong-A University Medical Center
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Inje University Busan Paik Hospital
Busan, 614-735, South Korea
Busan St. Mary's Hospital
Busan, South Korea
Busan Veterans Hospital
Busan, South Korea
Maryknoll Medical Center
Busan, South Korea
Changwon Fatima Hospital
Changwon, 51394, South Korea
Dankook University Hospital
Cheonan, 31116, South Korea
SoonChunHyang University Cheonan Hospital
Cheonan, 31151, South Korea
Hallym University ChunCheon Sacred Heart Hospital
Chuncheon, 24253, South Korea
Konkuk University Chungju Hospital
Chungju, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
Kyungpook national university medical center Chil-Gok
Daegu, 700-721, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
GangNeung Asan Hospital
Gangneung-si, South Korea
Dongguk University Ilsan Hospital
Goyang, 10326, South Korea
Myongji Hospital
Goyang, 10475, South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang-si, 10444, South Korea
Kumi Cha Hospital
Gumi, 39295, South Korea
Chosun University Hospital
Gwangju, 501-717, South Korea
Kwangju Christian Hospital
Gwangju, South Korea
Hanyang University Guri Hospital
Gyeonggi-do, 11923, South Korea
Dongguk University Gyeongju Hospital
Gyeongju, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
WonKwang University Hospital
Iksan, 54538, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 21431, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Cheju Halla General Hospital
Jeju City, 63127, South Korea
Presbyterian Medical Center
Jeonju, 54987, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, 660-702, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital
Seoul, 03722, South Korea
Seoul National University Hospital
Seoul, 03830, South Korea
SoonChunHyang University Hospital
Seoul, 04401, South Korea
Hanyang University Hospital
Seoul, 04763, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Kangdong Sacred Heart Hospital
Seoul, 05535, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
SMG - SNU Boramae Medical Center
Seoul, 07061, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Inje University Seoul Paik Hospital
Seoul, 100-032, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Eulji General Hospital
Seoul, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 41931, South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
DongKang Hospital
Ulsan, 44455, South Korea
Ulsan Hospital
Ulsan, 44686, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 49201, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 1, 2016
Study Start
December 5, 2016
Primary Completion
June 11, 2021
Study Completion
June 11, 2021
Last Updated
November 29, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share