Clinical trial NCT02951364: Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Keywords: observational
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 1081
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Korean individuals and pediatric Korean individuals aged 12 to \<18 years with genotype 1, 2, 4, 5, and 6 chronic HCV infection who are initiating commercial Harvoni regimen

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
timeFrame: Up to 30 days following treatment
measure: Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
Secondary outcomes:
measure: Incidence of Adverse Events (AEs) and Special Situation Reports (SSRs)
timeFrame: Up to Posttreatment Week 12
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggido
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon-si
country: Korea, Republic of
facility: SoonChunHyang University Bucheon Hospital
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon ST. Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Bumin Hospital Haeundae
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Good Gang-An Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Busan St. Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Busan Veterans Hospital
city: Busan
country: Korea, Republic of
facility: Maryknoll Medical Center
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: SoonChunHyang University Cheonan Hospital
city: Chuncheon-si
country: Korea, Republic of
facility: Hallym University ChunCheon Sacred Heart Hospital
city: Chungju-si
country: Korea, Republic of
facility: Konkuk University Chungju Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university medical center Chil-Gok
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung-si
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gumi
country: Korea, Republic of
facility: Kumi Cha Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Gyeongju-si
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Iksan
country: Korea, Republic of
facility: WonKwang University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju-si
country: Korea, Republic of
facility: Cheju Halla General Hospital
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Jinju-si
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Uijeongbu-si
country: Korea, Republic of
facility: The Catholic University of Korea Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Ulsan
country: Korea, Republic of
facility: DongKang Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
city: Wonju-si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: