Hepatitis C Virus Clinical Trial
Official title:
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Sovaldi in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
| Verified date | December 2021 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 2033 |
| Est. completion date | December 9, 2021 |
| Est. primary completion date | December 9, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | Key Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
| Korea, Republic of | SoonChunHyang University Bucheon Hospital | Bucheon-Si | |
| Korea, Republic of | The Catholic University of Korea Bucheon ST. Mary's Hospital | Bucheon-si | |
| Korea, Republic of | BongSeng Memorial Hospital | Busan | |
| Korea, Republic of | Busan St. Mary's Hospital | Busan | |
| Korea, Republic of | Busan Veterans Hospital | Busan | |
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | |
| Korea, Republic of | Maryknoll Medical Center | Busan | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | Changwon Fatima Hospital | Changwon | |
| Korea, Republic of | Dankook University Hospital | Cheonan | |
| Korea, Republic of | SoonChunHyang University Cheonan Hospital | Cheonan | |
| Korea, Republic of | Hallym University ChunCheon Sacred Heart Hospital | Chuncheon-si | |
| Korea, Republic of | Konkuk University Chungju Hospital | Chungju | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Kyungpook national university medical center Chil-Gok | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center | Daegu | |
| Korea, Republic of | Chungnam National University Hospital | Daejeon | |
| Korea, Republic of | Daejeon Eulji Medical Center | Daejeon | |
| Korea, Republic of | DaeJeon ST. Mary's Hospital | Daejeon | |
| Korea, Republic of | GangNeung Asan Hospital | Gangneung | |
| Korea, Republic of | Dongguk University Ilsan Hospital | Goyang | |
| Korea, Republic of | Myongji Hospital | Goyang | |
| Korea, Republic of | National Health Insurance Cooperation Ilsan Hospital | Goyang-si | |
| Korea, Republic of | Kumi Cha Hospital | Gumi | |
| Korea, Republic of | Hanyang University Guri Hospital | Guri | |
| Korea, Republic of | Konkuk University Medical Center | Gwangjin-gu | |
| Korea, Republic of | Chosun University Hospital | Gwangju | |
| Korea, Republic of | Kwangju Christian Hospital | Gwangju | |
| Korea, Republic of | Dongguk University Gyeongju Hospital | Gyeongju | |
| Korea, Republic of | Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | |
| Korea, Republic of | WonKwang University Hospital | Iksan | |
| Korea, Republic of | Catholic Kwandong University International St. Mary's Hospital | Incheon | |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | |
| Korea, Republic of | Inha University Hospital | Incheon | |
| Korea, Republic of | The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | |
| Korea, Republic of | Cheju Halla General Hospital | Jeju-Si | |
| Korea, Republic of | Presbyterian Medical Center | Jeonju | |
| Korea, Republic of | Chonbuk National University Hospital | Jeonju-si | |
| Korea, Republic of | Gyeongsang National University Hospital | Jinju | |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Boramae Medical Center | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Hanyang University Hospital | Seoul | |
| Korea, Republic of | Inje University Sanggye Paik Hospital | Seoul | |
| Korea, Republic of | Inje University Seoul Paik Hospital | Seoul | |
| Korea, Republic of | Kangbuk Samsung Hospital | Seoul | |
| Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Nowon Eulji Medical Center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Korea, Republic of | SoonChunHyang University Hospital | Seoul | |
| Korea, Republic of | CHA Bundang Medical Center | Sungnam | Gyeonggi-d |
| Korea, Republic of | Ajou University Hospital | Suwon | |
| Korea, Republic of | The Catholic University of Korea, St. Vincent's Hospital | Suwon-si | |
| Korea, Republic of | The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju | Gangwon-do |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | |
| Korea, Republic of | Yongin Severance Hospital | Yongin |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ) | 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment | ||
| Secondary | 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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