Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
1 other identifier
observational
2,033
1 country
72
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2016
CompletedFirst Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2021
CompletedDecember 27, 2021
December 1, 2021
5.3 years
September 16, 2016
December 23, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Study Arms (1)
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
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (72)
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
CHA Bundang Medical Center
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
Yŏngin, 17046, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 20, 2016
Study Start
September 9, 2016
Primary Completion
December 9, 2021
Study Completion
December 9, 2021
Last Updated
December 27, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share