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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02951364
Other study ID # GS-US-337-1966
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 5, 2016
Est. completion date June 11, 2021

Study information

Verified date November 2021
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
LDV/SOF
90/400 mg tablet administered orally once daily

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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