Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
- Conditions
- Hepatitis C Virus
- Interventions
- Drug: LDV/SOF
- Registration Number
- NCT02951364
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1081
- Individuals aged 12 years and older who are living in Korea
- Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form
Key
- Individuals treated with Harvoni outside of the approved prescribing information in Korea
- Individuals who have a contra-indication to Harvoni
- Individuals who have a contra-indication to ribavirin
- Pregnant or breastfeeding women
- Individuals who have previously been administered Harvoni
- 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 LDV/SOF LDV/SOF Adult Korean participants and pediatric Korean participants aged 12 to \<18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) Up to 30 days following treatment Incidence of adverse events (AEs) and special situation reports (SSRs) occurring during administration of Harvoni regimen or up to 30 days of treatments will be analyzed.
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 The sustained virologic response (SVR) rate will be assessed at 12 weeks after completion (or discontinuation) of Harvoni treatment, defined as the proportion of participants with HCV RNA \< lower limit of quantification (LLOQ) from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24 (based on when the participant's actual visit occurs). The treatment will be assessed as "improved/success" when HCV RNA \< LLOQ is achieved from 2 weeks before Posttreatment Week 12 through Posttreatment Week 24.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) Up to Posttreatment Week 12 Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed.
Trial Locations
- Locations (71)
Busan St. Mary's Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
WonKwang University Hospital
🇰🇷Iksan, Korea, Republic of
Dongguk University Gyeongju Hospital
🇰🇷Gyeongju-si, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
SoonChunHyang University Bucheon Hospital
🇰🇷Bucheon-si, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Kumi Cha Hospital
🇰🇷Gumi, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju-si, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wonju-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Incheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan Hospital
🇰🇷Ulsan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Konkuk University Chungju Hospital
🇰🇷Chungju-si, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
GangNeung Asan Hospital
🇰🇷Gangneung-si, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Gwangju, Korea, Republic of
Kyungpook national university medical center Chil-Gok
🇰🇷Daegu, Korea, Republic of
SoonChunHyang University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Goyang-si, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Hwaseong-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju-si, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, 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-si, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
DongKang Hospital
🇰🇷Ulsan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical Center
🇰🇷Seongnam-si, Gyeonggido, 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
Good Gang-An Hospital
🇰🇷Busan, Korea, Republic of
Bumin Hospital Haeundae
🇰🇷Busan, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Medical Center
🇰🇷Busan, Korea, Republic of
Maryknoll Medical Center
🇰🇷Busan, Korea, Republic of
Busan Veterans Hospital
🇰🇷Busan, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Hallym University ChunCheon Sacred Heart Hospital
🇰🇷Chuncheon-si, Korea, Republic of
SoonChunHyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Cheju Halla General Hospital
🇰🇷Jeju-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
SMG - SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of