Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
- Registration Number
- NCT02907996
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2033
- Individuals aged 12 years and older who are living in Korea
- 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
Key
- Individuals treated with Sovaldi outside of the approved prescribing information for Sovaldi in Korea
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sofosbuvir 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (71)
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
SoonChunHyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook national university medical center Chil-Gok
🇰🇷Daegu, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Korea, Republic of
Cheju Halla General Hospital
🇰🇷Jeju-Si, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Busan St. Mary's Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kumi Cha Hospital
🇰🇷Gumi, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Konkuk University Medical Center
🇰🇷Gwangjin-gu, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Busan Veterans Hospital
🇰🇷Busan, Korea, Republic of
Catholic Kwandong University International St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Chungju Hospital
🇰🇷Chungju, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Korea, Republic of
SoonChunHyang University Bucheon Hospital
🇰🇷Bucheon-Si, Korea, Republic of
Yongin Severance Hospital
🇰🇷Yongin, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju-si, Korea, Republic of
DaeJeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
National Health Insurance Cooperation Ilsan Hospital
🇰🇷Goyang-si, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Gwangju, Korea, Republic of
WonKwang University Hospital
🇰🇷Iksan, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Sungnam, Gyeonggi-d, Korea, Republic of
The Catholic University of Korea Bucheon ST. Mary's Hospital
🇰🇷Bucheon-si, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
BongSeng Memorial Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Maryknoll Medical Center
🇰🇷Busan, Korea, Republic of
Hallym University ChunCheon Sacred Heart Hospital
🇰🇷Chuncheon-si, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
GangNeung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Daejeon Eulji Medical Center
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Dongguk University Gyeongju Hospital
🇰🇷Gyeongju, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
SoonChunHyang University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of