Hepatitis C Virus Clinical Trial
Official title:
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Harvoni Treatment Regimen in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
| Verified date | November 2021 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1081 |
| Est. completion date | June 11, 2021 |
| Est. primary completion date | June 11, 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 - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | |
| 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 | Bumin Hospital Haeundae | Busan | |
| Korea, Republic of | Busan St. Mary's Hospital | Busan | |
| Korea, Republic of | Busan Veterans Hospital | Busan | |
| Korea, Republic of | Dong-A University Medical Center | Busan | |
| Korea, Republic of | Good Gang-An 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-si | |
| 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 | Konyang University Hospital | Daejeon | |
| Korea, Republic of | GangNeung Asan Hospital | Gangneung-si | |
| Korea, Republic of | Dongguk University Ilsan Hospital | Goyang | |
| Korea, Republic of | Myongji Hospital | Goyang | |
| Korea, Republic of | National Health Insurance Corporation Ilsan Hospital | Goyang-si | |
| Korea, Republic of | Kumi Cha Hospital | Gumi | |
| Korea, Republic of | Chosun University Hospital | Gwangju | |
| Korea, Republic of | Kwangju Christian Hospital | Gwangju | |
| Korea, Republic of | Hanyang University Guri Hospital | Gyeonggi-do | |
| Korea, Republic of | Dongguk University Gyeongju Hospital | Gyeongju-si | |
| 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 | 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-si | |
| Korea, Republic of | CHA Bundang Medical Center | Seongnam-si | Gyeonggido |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Chung-Ang University Hospital | Seoul | |
| Korea, Republic of | Eulji General Hospital | Seoul | |
| Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
| Korea, Republic of | Gangnam Severance 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 | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | 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 | SMG - SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | SoonChunHyang University 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 | DongKang Hospital | Ulsan | |
| Korea, Republic of | Ulsan Hospital | Ulsan | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Yonsei University Wonju Severance Christian Hospital | Wonju-si | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) | 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. | Up to 30 days following treatment | |
| Primary | Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | 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. | Posttreatment Week 12 | |
| Secondary | Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs) | Incidence of adverse events (AEs) and special situation reports (SSRs) occurring within 12 weeks after completion (or discontinuation) of treatments will be analyzed. | Up to Posttreatment Week 12 |
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