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The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results to Korean Ministry of Food and Drug Safety (MFDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any Adverse Events (AEs) Occurring During Administration of Sovaldi Regimens or Within 30 Days After Completion (or Discontinuation) of Sovaldi Treatment Regimens | First dose date up to 30 days posttreatment | |
| Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ) | 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens | First dose date up to 12 weeks posttreatment |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Adult Korean individuals with Genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean individuals (aged 12 to <18 years) with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea | ||
| CHA Bundang Medical Center |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Sungnam |
| Gyeonggi-d |
| 463-712 |
| South Korea |
| Hallym University Sacred Heart Hospital | Anyang | 14068 | South Korea |
| The Catholic University of Korea Bucheon ST. Mary's Hospital | Bucheon-si | 14647 | South Korea |
| SoonChunHyang University Bucheon Hospital | Bucheon-si | 420-767 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| BongSeng Memorial Hospital | Busan | 48775 | South Korea |
| Dong-A University Hospital | 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 | 27376 | 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 |
| DaeJeon ST. Mary's Hospital | Daejeon | 301-723 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Daejeon Eulji Medical Center | Daejeon | 35233 | South Korea |
| GangNeung Asan Hospital | Gangneung | 25440 | South Korea |
| Dongguk University Ilsan Hospital | Goyang | 10326 | South Korea |
| Myongji Hospital | Goyang | 10475 | South Korea |
| National Health Insurance Cooperation Ilsan Hospital | Goyang-si | 10444 | South Korea |
| Kumi Cha Hospital | Gumi | 39295 | South Korea |
| Hanyang University Guri Hospital | Guri-si | 11923 | South Korea |
| Konkuk University Medical Center | Gwangjin-gu | 05030 | South Korea |
| Chosun University Hospital | Gwangju | 501-717 | South Korea |
| Kwangju Christian Hospital | Gwangju | 61661 | South Korea |
| Dongguk University Gyeongju Hospital | Gyeongju | 38067 | 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 |
| Catholic Kwandong University International St. Mary's Hospital | Incheon | 22711 | 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 | 52727 | 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 |
| Seoul National University Hospital | Seoul | 03830 | South Korea |
| SoonChunHyang University Hospital | Seoul | 04401 | South Korea |
| Hanyang University Hospital | Seoul | 04763 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | 05535 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| 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 |
| Severance Hospital | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | South Korea |
| Nowon Eulji Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | 16499 | 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 | 11765 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| Yongin Severance Hospital | Yongin | 17046 | South Korea |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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