Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
NCT ID: NCT02951364
Last Updated: 2021-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1081 participants
OBSERVATIONAL
2016-12-05
2021-06-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
LDV/SOF
90/400 mg tablet administered orally once daily
Interventions
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LDV/SOF
90/400 mg tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggido, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, , South Korea
SoonChunHyang University Bucheon Hospital
Bucheon-si, , South Korea
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, , South Korea
Bumin Hospital Haeundae
Busan, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
Good Gang-An Hospital
Busan, , South Korea
Dong-A University Medical Center
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Inje University Busan Paik Hospital
Busan, , 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, , South Korea
Dankook University Hospital
Cheonan, , South Korea
SoonChunHyang University Cheonan Hospital
Cheonan, , South Korea
Hallym University ChunCheon Sacred Heart Hospital
Chuncheon, , South Korea
Konkuk University Chungju Hospital
Chungju, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Kyungpook national university medical center Chil-Gok
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Konyang University Hospital
Daejeon, , South Korea
GangNeung Asan Hospital
Gangneung-si, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Myongji Hospital
Goyang, , South Korea
National Health Insurance Corporation Ilsan Hospital
Goyang-si, , South Korea
Kumi Cha Hospital
Gumi, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Kwangju Christian Hospital
Gwangju, , South Korea
Hanyang University Guri Hospital
Gyeonggi-do, , 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, , South Korea
WonKwang University Hospital
Iksan, , South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Cheju Halla General Hospital
Jeju City, , South Korea
Presbyterian Medical Center
Jeonju, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
SoonChunHyang University Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , 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, , South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
DongKang Hospital
Ulsan, , South Korea
Ulsan Hospital
Ulsan, , South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Other Identifiers
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GS-US-337-1966
Identifier Type: -
Identifier Source: org_study_id