Clinical trial NCT02907996: Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 2033
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Korean individuals with Genotype 1, 2, 3, and 4 chronic HCV infection and pediatric Korean individuals (aged 12 to \<18 years) with genotype 2 and 3 chronic HCV infection who are initiating commercial Sovaldi regimens.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: First dose date up to 30 days posttreatment
measure: Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ)
timeFrame: 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
Secondary outcomes:
measure: Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens
timeFrame: First dose date up to 12 weeks posttreatment
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Sungnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-d
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon-si
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon ST. Mary's Hospital
city: Bucheon-Si
country: Korea, Republic of
facility: SoonChunHyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: BongSeng Memorial Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
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
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: DaeJeon ST. Mary's Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon Eulji Medical Center
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Cooperation 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: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Gwangjin-gu
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Gyeongju
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: Catholic Kwandong University International St. Mary's 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
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: 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: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: 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: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
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: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: