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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02907996
Other study ID # GS-US-334-1967
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2016
Est. completion date December 9, 2021

Study information

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

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 2033
Est. completion date December 9, 2021
Est. primary completion date December 9, 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 - 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.

Study Design


Intervention

Drug:
Sofosbuvir
400 mg tablet administered orally once daily

Locations

Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang
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 BongSeng Memorial Hospital Busan
Korea, Republic of Busan St. Mary's Hospital Busan
Korea, Republic of Busan Veterans Hospital Busan
Korea, Republic of Dong-A University 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
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 Daejeon Eulji Medical Center Daejeon
Korea, Republic of DaeJeon ST. Mary's Hospital Daejeon
Korea, Republic of GangNeung Asan Hospital Gangneung
Korea, Republic of Dongguk University Ilsan Hospital Goyang
Korea, Republic of Myongji Hospital Goyang
Korea, Republic of National Health Insurance Cooperation Ilsan Hospital Goyang-si
Korea, Republic of Kumi Cha Hospital Gumi
Korea, Republic of Hanyang University Guri Hospital Guri
Korea, Republic of Konkuk University Medical Center Gwangjin-gu
Korea, Republic of Chosun University Hospital Gwangju
Korea, Republic of Kwangju Christian Hospital Gwangju
Korea, Republic of Dongguk University Gyeongju Hospital Gyeongju
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 Catholic Kwandong University International St. Mary's Hospital Incheon
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
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Boramae Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Ewha Womans University Mokdong 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 Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Nowon Eulji Medical Center 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 SoonChunHyang University Hospital Seoul
Korea, Republic of CHA Bundang Medical Center Sungnam Gyeonggi-d
Korea, Republic of Ajou University Hospital Suwon
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
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju Gangwon-do
Korea, Republic of Pusan National University Yangsan Hospital Yangsan
Korea, Republic of Yongin Severance Hospital Yongin

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 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 First dose date up to 30 days posttreatment
Primary Proportion of Participants with HCV RNA < Lower Limit of Quantification (LLOQ) 2 weeks before Posttreatment Week 12 through Week 24 Posttreatment
Secondary Percentage of Participants Experiencing Any AEs Occurring During Administration of Sovaldi Regimens or Within 12 Weeks After Completion (or Discontinuation) of Sovaldi Treatment Regimens First dose date up to 12 weeks posttreatment
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