Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
NCT ID: NCT02907996
Last Updated: 2021-12-27
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
2033 participants
OBSERVATIONAL
2016-09-09
2021-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Sofosbuvir
Adult Korean participants with genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean participants aged 12 to \<18 years with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens
Sofosbuvir
400 mg tablet administered orally once daily
Interventions
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Sofosbuvir
400 mg tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with chronic HCV infection eligible for treatment with Sovaldi as indicated in the approved prescribing information for Sovaldi
* Individuals who have been informed of all pertinent aspects of the study and have voluntarily signed Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have their legally authorized representatives sign the PIPA consent form
Exclusion Criteria
* Individuals who have a contra-indication (refer to the Korea prescribing information)
* Individuals who have a contra-indication to ribavirin or peginterferon alfa or daclatasvir
* Pregnant or breast feeding women
* Individuals who have previously been administered Sovaldi
* 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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Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
CHA Bundang Medical Center
Sungnam, Gyeonggi-d, South Korea
Hallym University Sacred Heart Hospital
Anyang, , South Korea
The Catholic University of Korea Bucheon ST. Mary's Hospital
Bucheon-si, , South Korea
SoonChunHyang University Bucheon Hospital
Bucheon-si, , South Korea
Inje University Haeundae Paik Hospital
Busan, , South Korea
BongSeng Memorial Hospital
Busan, , South Korea
Dong-A University Hospital
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
DaeJeon ST. Mary's Hospital
Daejeon, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Daejeon Eulji Medical Center
Daejeon, , South Korea
GangNeung Asan Hospital
Gangneung, , South Korea
Dongguk University Ilsan Hospital
Goyang, , South Korea
Myongji Hospital
Goyang, , South Korea
National Health Insurance Cooperation Ilsan Hospital
Goyang-si, , South Korea
Kumi Cha Hospital
Gumi, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Konkuk University Medical Center
Gwangjin-gu, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Kwangju Christian Hospital
Gwangju, , 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
Catholic Kwandong University International St. Mary's 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
Seoul National University Hospital
Seoul, , South Korea
SoonChunHyang University Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Inje University Sanggye Paik Hospital
Seoul, , South Korea
Nowon Eulji Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , 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
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Yongin Severance Hospital
Yŏngin, , South Korea
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-334-1967
Identifier Type: -
Identifier Source: org_study_id